Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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DateProductReasonClassFirm
Oct 19, 2023 Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 19, 2023 CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h... Class II CardioQuip, LLC
Oct 19, 2023 Integra Cranial access kit (without Prep solutions) Bit and Guard-For access ... Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without... Class II Integra LifeSciences Corp.
Oct 19, 2023 Medline Leg bag, REF DYND12574 Undeclared latex Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 19, 2023 Medline Leg bag, REF URO12573 Undeclared latex Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 19, 2023 Integra Cranial Access Kit - For access to the subarachnoid space or the late... Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... Class II Integra LifeSciences Corp.
Oct 18, 2023 LYFO-DISK, P. venetum, Catalog number 0794L A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... Class II Microbiologics Inc
Oct 18, 2023 Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w Their is the potential that software issues may result in flipped image of the virtual Bronchosc... Class II AURIS HEALTH INC
Oct 18, 2023 Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w Their is the potential that software issues may result in flipped image of the virtual Bronchosc... Class II AURIS HEALTH INC
Oct 18, 2023 KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... Class II Microbiologics Inc
Oct 18, 2023 Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w Their is the potential that software issues may result in flipped image of the virtual Bronchosc... Class II AURIS HEALTH INC
Oct 17, 2023 FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base w... Due to an increased risk of degradation of the power entry switch resulting from arcing inside of... Class II BioFire Diagnostics, LLC
Oct 17, 2023 ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11... Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-... Class II Siemens Medical Solutions USA, Inc
Oct 17, 2023 SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. Class II Bebig Isotopentechnik Gmbh
Oct 17, 2023 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, use... Routine quality control testing of affected blood culture identification panel with affected cont... Class II BioFire Diagnostics, LLC
Oct 17, 2023 Lugol s Iodine Solution 500ML, Part Number 624-71 Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap ... Class II EMD Millipore Corporation
Oct 16, 2023 (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Train... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality ... Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws ... Class II Zimmer Biomet Spine Inc.
Oct 16, 2023 GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to... Class II Aizu Olympus Co., Ltd.
Oct 16, 2023 GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to... Class II Aizu Olympus Co., Ltd.
Oct 16, 2023 CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to... Class II Aizu Olympus Co., Ltd.
Oct 16, 2023 PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to... Class II Aizu Olympus Co., Ltd.
Oct 16, 2023 Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with ... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to... Class II Aizu Olympus Co., Ltd.
Oct 13, 2023 AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product cod... Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not bei... Class II Avanos Medical, Inc.
Oct 13, 2023 Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revisi... Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity... Class II Corin Ltd
Oct 13, 2023 Novum IQ Syringe infusion system, Product Code 40800BAXUS Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter ident... Class I Baxter Healthcare Corporation
Oct 13, 2023 with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 0060... Produced with unintended open slits on the side of the mouthpiece body, may result in insufficien... Class II Breas Medical, Inc.
Oct 13, 2023 Unity Total Knee System, Model Number 112.001.34. Primary and revision t... Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity... Class II Corin Ltd
Oct 12, 2023 Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2... Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.... Class II CHANGE HEALTHCARE CANADA COMPANY
Oct 12, 2023 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 an... There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1T... There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 B... There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbe... It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail ... Class II Maquet Medical Systems USA
Oct 12, 2023 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 11, 2023 NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal l... May have increased water path restriction within the heat exchanger, leading to degraded heat exc... Class II Mc3 Inc
Oct 11, 2023 Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multipl... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 VariSoft infusion set, Model Number 1002830 The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... Class I Unomedical A/S
Oct 11, 2023 RANDOX Total Bilirubin. Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with To... Class II Randox Laboratories Ltd.
Oct 11, 2023 BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump In... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 11, 2023 VariSoft infusion set, Model Number 1002827 The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... Class I Unomedical A/S
Oct 11, 2023 Curaplex manual resuscitators with integrated manometer, multiple accessory c... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension ... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company

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.