Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Aug 29, 2024 Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Steril... Specific lots of product have been manufactured with nonconforming raw materials. Class II Wilson-Cook Medical Inc.
Aug 28, 2024 MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ... CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable En... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE HEART CABG CDS, REF CDS983376R Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE KIT CV I II, REF DYNJ906071B Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART, REF DYNJ904261B Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART PACK, REF DYNJ66216C Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent im... Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hor... Class II Beckman Coulter, Inc.
Aug 27, 2024 HAWK Warming Grid, Item Number: 59-300 Incorrect expiration date. Class II Safeguard US Operating LLC
Aug 27, 2024 Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-3... Incorrect expiration date. Class II Safeguard US Operating LLC
Aug 27, 2024 HAWK Advanced Hypothermia Management Set, Item Number: 59-320 Incorrect expiration date. Class II Safeguard US Operating LLC
Aug 26, 2024 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/C... Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... Class II Nova Ortho-Med Inc
Aug 26, 2024 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model... Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... Class II Nova Ortho-Med Inc
Aug 26, 2024 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Ca... Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... Class II Nova Ortho-Med Inc
Aug 26, 2024 FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the F... Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect in... Class II Qualigen Inc
Aug 23, 2024 Diode Laser Hair Removal model: WLA-01 All model WLA-01 systems sold to US customers are found to have labeling non-compliances Class II WINGDERM ELECTRO-OPTICS LTD.
Aug 23, 2024 Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of h... This recall was initiated due to customer complaints of false negative of hCG test results when r... Class II Princeton Biomeditech Corp
Aug 23, 2024 AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision ... Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for ... Class II Stryker Spine
Aug 23, 2024 Non-ablative Fractional Laser Systems, Model: WFB-01 Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 un... Class II WINGDERM ELECTRO-OPTICS LTD.
Aug 23, 2024 BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net con... The bulk product used in the recalling firm's repackaged finished product was recalled due to bac... Class II Young Dental Manufacturing I, LLC
Aug 23, 2024 Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing... Class II Olympus Corporation of the Americas
Aug 22, 2024 StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stea... Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navig... Class II Medtronic Navigation, Inc.
Aug 22, 2024 Healgen Series Reagent strips for Urinalysis are composed of several color pa... The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent S... Class II Healgen Scientific Llc
Aug 22, 2024 System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 ... Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 22, 2024 System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-... Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 22, 2024 System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 7... Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 22, 2024 System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagno... Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 21, 2024 ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (5... Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... Class II Siemens Healthcare Diagnostics, Inc.
Aug 21, 2024 Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-... Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not h... Class II XTANT Medical Holdings, Inc
Aug 21, 2024 Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2... A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 21, 2024 McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 21, 2024 Vanta Implantable Neurostimulator (INS), Model 977006 Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading t... Class II Medtronic Neuromodulation
Aug 21, 2024 Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 It was discovered during device performance testing that the CCD imaging sensors were programmed ... Class II Olympus Corporation of the Americas
Aug 21, 2024 da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS50... Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomi... Class II Intuitive Surgical, Inc.
Aug 21, 2024 Horizon Cardiology Hemo. Version 12.2. A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... Class II CHANGE HEALTHCARE CANADA COMPANY
Aug 21, 2024 Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500... Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... Class II Siemens Healthcare Diagnostics, Inc.
Aug 20, 2024 BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 Due to a classification error in our inventory management system, these medical devices were ship... Class II Cypress Medical Products LLC
Aug 20, 2024 Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 Due to a classification error in our inventory management system, these medical devices were ship... Class II Cypress Medical Products LLC
Aug 20, 2024 Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: ... Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar ... Class II Ossur H / F
Aug 19, 2024 BlueFIRE Inflation Device, REF: IN10140 Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixTOUCH Inflation Device, REF: IN8140/A Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 StabiliT TOUCH Syringe, REF: IN8VCF/B Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 IntelliSystem Inflation Device, REF: IN1525/D Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Versio... Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when use... Class II Hologic Inc
Aug 19, 2024 MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixSKY Inflation Device, REF: SKY1802 Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.