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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

Clear
DateProductReasonClassFirm
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 20, 2023 HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... Some catheters had a manufacturing defect where the clear resealing label separating from the pro... Class II C.R. Bard Inc
Apr 19, 2023 Patient Information Center iX, Product Code 866386, and Patient Information C... During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto... Class II Philips North America
Apr 18, 2023 Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA II... The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the end... Class II Olympus Corporation of the Americas
Apr 17, 2023 ID Coax 180, MP03375 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Coax (P) 150, MP00379 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (P) 180 w/oLL, MP00362 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Total Knee Pack, REF CETJ130, medical convenience kits Incorrect expiration date on product. Class III American Contract Systems, Inc.
Apr 17, 2023 VentStar Bag Set (N) 110, MP00383 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax 230, MP03376 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax HEPA, MP17102 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar breathing bag Set (P) 110, MP00384 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (N) 180, MP00353 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK,... The custom procedure packs contain light handle covers that have been recalled by another firm. Class II DeRoyal Industries Inc
Apr 17, 2023 Anesthesia Circuit Kit Coax 1, MP02730 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax 180, MP03374 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax 3, MP02732 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (P)250, MP00352 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 ID Circuit Basic (P) 180, MP01340 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax, MP03373 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Anesthesia (N) 180, MP00333 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (P) 180, MP00361 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (N) 180, MP00363 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determi... Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis Class II Ortho-Clinical Diagnostics, Inc.
Apr 17, 2023 Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood p... The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. Class I Abiomed, Inc.
Apr 17, 2023 Anesthesia Set Coax 180, MP03384 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTIO... The custom procedure packs contain light handle covers that have been recalled by another firm. Class II DeRoyal Industries Inc
Apr 17, 2023 VentStar Anesthesia WT (P)180, MP00374 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Seattle PAP Plus, MP02260 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Set2Go Ventilation 12 (A), MP07968 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (P)180, MP00351 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 14, 2023 RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagn... QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labell... Class III Mechatronics USA
Apr 14, 2023 VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 ... Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in ... Class II Ortho-Clinical Diagnostics, Inc.
Apr 14, 2023 RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vit... QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labell... Class III Mechatronics USA
Apr 14, 2023 REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only N... Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Com... Class II Stryker Sustainability Solutions
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone ... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone f... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to ... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 12, 2023 Ultraview SL (UVSL) Command Module, Model 91496 Command modules will display the following when parameter processing is suspended, depending on s... Class II Spacelabs Healthcare, Inc.
Apr 12, 2023 Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Nu... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Nu... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: ... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 400... The product contains an expired diluent vial. If the impacted product is used, the sterility of t... Class II TELEFLEX LLC
Apr 12, 2023 Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: ... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 11, 2023 Codman Cranial Hand Drill- Indicated when a craniotomy is required for placem... Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Dril... Class II Integra LifeSciences Corp.
Apr 11, 2023 StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/... In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection ... Class I Medtronic Navigation, 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.