RecallsBAMAMON Recalls LED Projecting Finger Light Toys Due to Risk of Serious Injury orNews Paper Joint
Recalls
Data updated Oct 28, 2026 · 6:02 AM EDT
Medical Device Recalls Today
Medical Device recalls and enforcement reports from the FDA, last 120 days
Recalls Listed
60
Last 120 days
Last 30 Days
60
New reports
Class I
2
Most serious risk
Snapshot
The FDA has published 60 medical device recall reports in the last 30 days. The most recent, reported October 21, involves TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. from Howmedica Osteonics Corp. — reason: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays… Class I recalls are the most serious, meaning the product could cause serious health problems or death.
Latest Medical Device Recalls
Class IIOct 21, 2026
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.Reason: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may…
Howmedica Osteonics Corp. · Distribution: These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will… · Ongoing
Class IIOct 21, 2026
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821Reason: Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or…
Ferno-Washington Inc · Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, ID,… · Ongoing
Class IIOct 21, 2026
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.Reason: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may…
Howmedica Osteonics Corp. · Distribution: These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will… · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A;…Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IOct 21, 2026
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Instrumentation Laboratory · Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA,… · Ongoing
Class IIOct 21, 2026
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112Reason: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur…
Cook Incorporated · Distribution: US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland. · Ongoing
Class IIOct 21, 2026
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having…Reason: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the…
Medtronic Sofamor Danek USA Inc · Distribution: US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL,… · Ongoing
Class IIOct 21, 2026
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395AReason: Discrepancy in the shelf-life of a component
Medline Industries, LP · Distribution: US Nationwide distribution in the state of NY. · Ongoing
Class IIOct 21, 2026
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731MReason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or…
Medline Industries, LP · Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898DReason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845DReason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIIOct 21, 2026
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.Reason: In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July…
Magellan Diagnostics, Inc. · Distribution: US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY. · Ongoing
Class IIOct 21, 2026
Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122005NA Product Description: LIKORALL 242…Reason: Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected…
Baxter Healthcare Corporation · Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado,… · Ongoing
Class IIOct 21, 2026
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513Reason: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the…
Beckman Coulter, Inc. · Distribution: Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY,… · Ongoing
Class IIOct 21, 2026
Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG901002D GENERAL DAVINCI DYNJG901004B DYNJG901004D HERNANDEZ DAVINCI ACC…Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or…
Medline Industries, LP · Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA,…Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB; 3) CATH LAB ENDO…Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having…Reason: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the…
Medtronic Sofamor Danek USA Inc · Distribution: US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL,… · Ongoing
Class IIOct 21, 2026
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product…Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
BioFire Diagnostics, LLC · Distribution: Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ,… · Ongoing
Class IOct 21, 2026
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnosticReason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Instrumentation Laboratory · Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA,… · Ongoing
Class IIOct 21, 2026
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8…Reason: Following a Chromium-based web-browser, report and displayed images may not match.
INTELERAD MEDICAL SYSTEMS INCORPORATED · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.Reason: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may…
Howmedica Osteonics Corp. · Distribution: These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will… · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF,…Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116GReason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or…
Medline Industries, LP · Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. · Ongoing
Class IIOct 21, 2026
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a…Reason: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing…
Radiometer Medical ApS · Distribution: US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL,… · Ongoing
Class IIOct 21, 2026
Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low…Reason: Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to…
Cadwell Industries Inc · Distribution: Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam,… · Ongoing
Class IIOct 21, 2026
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)Reason: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
SI-BONE, Inc. · Distribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. · Ongoing
Class IIOct 21, 2026
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mmReason: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
In2bones USA, LLC · Distribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product…Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683Reason: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the…
Beckman Coulter, Inc. · Distribution: Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY,… · Ongoing
Class IIOct 21, 2026
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-LReason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Jenavalve Technology Inc. · Distribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN,… · Ongoing
Class IIOct 21, 2026
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115Reason: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from…
Steris Corporation · Distribution: Worldwide - US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SPReason: Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting…
Microgenics Corporation · Distribution: Worldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX, CA, LA,… · Ongoing
Class IIOct 21, 2026
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding…Reason: The potential for the devices to be mislabeled with the incorrect length.
W L Gore & Associates, Inc. · Distribution: US Nationwide distribution in the states of GA, RI. · Ongoing
Class IIOct 21, 2026
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-MReason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Jenavalve Technology Inc. · Distribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN,… · Ongoing
Class IIOct 21, 2026
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271HReason: Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay.…
Ethicon, LLC · Distribution: Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO,… · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline…Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117Reason: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from…
Steris Corporation · Distribution: Worldwide - US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
FORWARD Gunshot Wound Kit; Model: AFT-GSW;Reason: Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The…
INTEGRATED MEDCRAFT LLC · Distribution: US Nationwide distribution in the states of GA, VA. · Ongoing
Class IIOct 21, 2026
Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type…Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
BioFire Diagnostics, LLC · Distribution: Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ,… · Ongoing
Class IIOct 21, 2026
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT…Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474FReason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or…
Medline Industries, LP · Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. · Ongoing
Class IIOct 21, 2026
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KITReason: Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
Sarnova HC, Llc · Distribution: US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH,… · Ongoing
Class IIOct 21, 2026
Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI PROSTATE ACCESSORY DYNJ63392D…Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or…
Medline Industries, LP · Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. · Ongoing
Class IIOct 21, 2026
BD Phoenix Panel NMIC-312. Catalog Number: 449082.Reason: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Becton Dickinson & Co. · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model…Reason: Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
Healthmark Industries Co., Inc. · Distribution: Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO… · Ongoing
Class IIOct 21, 2026
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EOReason: The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
Merit Medical Systems, Inc. · Distribution: US: AZ, CA, FL, IN, LA, NV, RI OUS: None · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925DReason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720AReason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or…
Medline Industries, LP · Distribution: US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. · Ongoing
Class IIOct 21, 2026
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-SReason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Jenavalve Technology Inc. · Distribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN,… · Ongoing
Class IIOct 21, 2026
BD Phoenix Panel NMIC-306. Catalog Number: 449292.Reason: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Becton Dickinson & Co. · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.Reason: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may…
Howmedica Osteonics Corp. · Distribution: These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will… · Ongoing
Class IIOct 21, 2026
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are…Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
BioFire Diagnostics, LLC · Distribution: Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ,… · Ongoing
Class IIOct 21, 2026
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;Reason: Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
Boston Scientific Corporation · Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC,… · Ongoing
Class IIOct 21, 2026
Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4)…Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medline Industries, LP · Distribution: US Nationwide distribution. · Ongoing
Class IIOct 21, 2026
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number:…Reason: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Neuronetics, Inc. · Distribution: Worldwide distribution - US Nationwide and the countries of Japan and South Korea. · Ongoing
Class IIOct 21, 2026
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116Reason: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from…
Steris Corporation · Distribution: Worldwide - US Nationwide distribution. · Ongoing
Class IIOct 14, 2026
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007Reason: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or…
Stryker Sustainability Solutions · Distribution: US Nationwide distribution in the state of NJ. · Ongoing
Class IIOct 14, 2026
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will…
Steris Corporation · Distribution: Worldwide - US Nationwide distribution. · Ongoing
Latest Recalls News
All news →RecallsCostway Recalls Convertible High Chairs Due to Risk of Serious Injury or Death fromNews Paper Joint
RecallsFoShanShiNanHaiQuNuoAiTongZhuangShangHang Recalls CIYTI Light-Up Princess Costumes Due to Risk of Serious Injury or DeathNews Paper Joint
RecallsLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arm Mountings Due to Risk ofNews Paper Joint
Frequently Asked Questions
What do FDA recall classes mean?
Class I: a reasonable probability the product will cause serious health problems or death. Class II: may cause temporary or medically reversible problems. Class III: unlikely to cause adverse health consequences.
What should I do if I have a recalled product?
Stop using it, check the lot or batch number against the recall, and follow the company's instructions for a refund or disposal. Contact a doctor if you think you have been harmed.
Data source & method: U.S. Food & Drug Administration (openFDA). Data updated Oct 28, 2026 · 6:02 AM EDT. This page refreshes automatically; figures are shown exactly as published by the source. How we source data.