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Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
Aug 8, 2018 ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mm... Two units in distribution were found to be mislabeled on the vial cap with the incorrect part num... Class II Implant Direct Sybron Manufacturing, LLC
Aug 8, 2018 Bronchofiberscope BF-XT40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope BF-XP60 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchofiberscope BF-XP40 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchovideoscope BF-Q180-AC The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Produc... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bronchovideoscope BF-Q180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchofibercope BF-6C240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-XT160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope BF-P240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchovideoscope F-1TQ180 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Bronchofiberscope F-1T160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Ultrasonic Bronchoscope BF-UC160F-OL8 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchovideoscope BF-240 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Rhino Laryngo scope ENF-VT2 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchovideoscope BF-XP160F The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 7, 2018 Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE,... There is a potential security vulnerability related to the use of the remote controller accessori... Class I Medtronic Inc.
Aug 7, 2018 Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503U... There is a potential security vulnerability related to the use of the remote controller accessori... Class I Medtronic Inc.
Aug 7, 2018 ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, R... The incorrect device was packaged in the vial. Class II Implant Direct Sybron Manufacturing, LLC
Aug 6, 2018 AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table... In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe... Class II Siemens Medical Solutions USA, Inc
Aug 6, 2018 Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7... In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe... Class II Siemens Medical Solutions USA, Inc
Aug 6, 2018 Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 o... In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe... Class II Siemens Medical Solutions USA, Inc
Aug 6, 2018 Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monop... The Manual cleaning process and the usability of the reprocessing instruction by the user had not... Class III Dannoritzer Medizintechnik GmbH & Co. KG
Aug 6, 2018 Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene mal... Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal b... Class II Reckitt Benckiser LLC
Aug 3, 2018 Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol i... Expiration date incorrectly listed on the label Class II Zimmer Biomet, Inc.
Aug 3, 2018 Multix Fusion system is a radiographic system: Models: Multix Fusion Analog... Steel cables inside the lifting column of the overhead tube, may rapture without triggering the ... Class II Siemens Medical Solutions USA, Inc
Aug 3, 2018 Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/C... Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnost... Class II Agfa Healthcare NV
Aug 3, 2018 MOSAIQ Oncology Information System Order Status Remains Approved When Should Indicate Complete. Class II Elekta, Inc.
Aug 3, 2018 Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Versio... Released with an incorrect, older firmware version installed. May result in intermittent loss of... Class II Invivo Corporation

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.