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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

1,683 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,683 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 1,683 FDA device recalls in 2026.

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DateProductReasonClassFirm
May 21, 2026 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 CRE Pro Wireguided 12-15mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 0080174112160... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD C... Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may ... Class II BD SWITZERLAND SARL
May 21, 2026 MOSAIQ Oncology Information System Software may fail to load adapted baseline shift plan during treatment delivery when a communicat... Class II Elekta, Inc.
May 20, 2026 Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and ... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PS... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left ... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 ARTIS icono ceiling. Model Number: 11328100. Potential for loss of movement capability after adjusting the detector lift height to its maximum... Class II Siemens Medical Solutions USA, Inc
May 20, 2026 Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (... External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... Class I Insulet Corporation
May 20, 2026 ARTIS icono biplane. Model Number: 11327600. Potential for loss of movement capability after adjusting the detector lift height to its maximum... Class II Siemens Medical Solutions USA, Inc
May 20, 2026 ARTIS icono floor. Model Number: 11327700. Potential for loss of movement capability after adjusting the detector lift height to its maximum... Class II Siemens Medical Solutions USA, Inc
May 20, 2026 Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525... External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... Class I Insulet Corporation
May 20, 2026 RayCare 2024A SP4. Oncology Information Systems. Beam set delivery note issues in which there is potential data loss if the beam set delivery note... Class II RAYSEARCH LABORATORIES AB
May 20, 2026 Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720... External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... Class I Insulet Corporation
May 20, 2026 RayCare 2024A SP1. Oncology Information Systems. Beam set delivery note issues in which there is potential data loss if the beam set delivery note... Class II RAYSEARCH LABORATORIES AB
May 20, 2026 Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guid... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 20, 2026 Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 20, 2026 Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog ... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 20, 2026 Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 20, 2026 Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Gui... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 19, 2026 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKC... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II AVID Medical, Inc.
May 19, 2026 Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (ki... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II AVID Medical, Inc.
May 19, 2026 Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/I... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II AVID Medical, Inc.
May 19, 2026 American Contract Systems medical procedure kits and trays labeled as: 1) ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II American Contract Systems Inc
May 19, 2026 American Contract Systems medical procedure kits and trays labeled as: 1) ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II American Contract Systems Inc
May 19, 2026 Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. C... Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper s... Class II AVID Medical, Inc.
May 19, 2026 Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the b... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
May 19, 2026 Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the be... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
May 19, 2026 GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numb... Due to catheter separation Class II W L Gore & Associates, Inc.
May 19, 2026 TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... Class II Howmedica Osteonics Corp.
May 19, 2026 TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... Class II Howmedica Osteonics Corp.
May 19, 2026 Medtronic O-arm O2 Imaging System. Model Number: BI70002000. Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector pane... Class II Medtronic Navigation, Inc.-Boxborough
May 18, 2026 ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test Sy... The use of a non-validated rework process for assay reagents which could lead to missed diagnosis... Class II Bioporto Diagnostics A/S
May 18, 2026 GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnost... Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of ru... Class II WALLAC OY
May 18, 2026 Philips Allura Xper with the following Model Numbers: Model # 722001 for Allu... Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing poten... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 18, 2026 Philips MultiDiagnost Eleva with the following Model Numbers: Model # 7080... Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing poten... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 18, 2026 Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, ... Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms ... Class I Abiomed, Inc.
May 18, 2026 DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing... Sterile wound dressing, lacks sterility assurance Class II DeRoyal Industries Inc
May 15, 2026 Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. ... Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of res... Class I Medline Industries, LP
May 15, 2026 ALYON Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class II Steris Corporation
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. Class II Steris Corporation
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class II Steris Corporation
May 14, 2026 ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optica... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. ... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optic... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optic... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optica... Potential for overpressure alerts. Class II ConMed 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.