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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

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Apr 17, 2025 Tornado Embolization Microcoil, intended for embolization of selective vessel... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Apr 17, 2025 Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Apr 17, 2025 Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-... Cook Medical identified that devices from the affected device lots may contain the incorrectly si... Class II Cook Incorporated
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Num... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Num... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Feb 27, 2025 NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-co... The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with ... Class II Zimmer, Inc.
Feb 12, 2025 Z1 Femoral Hip System, Product Number 611777612 There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the d... Class II Zimmer, Inc.
Jan 6, 2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D ... It was identified internally that two commingle events occurred where the metal support post with... Class II Zimmer, Inc.
Jan 6, 2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F ... It was identified internally that two commingle events occurred where the metal support post with... Class II Zimmer, Inc.
Nov 22, 2024 Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Nov 22, 2024 Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, RE... Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Nov 22, 2024 Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Ste... Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... Class II Cook Biotech, Inc.
Oct 21, 2024 JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 Firm received complaints reporting that guides were warped when pulled out of packaging. This iss... Class II Biomet, Inc.
Oct 17, 2024 cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, fo... Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Ass... Class II Roche Diagnostics Operations, Inc.
Oct 14, 2024 Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Devices from the affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 8, 2024 Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference P... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 8, 2024 Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numb... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Sep 26, 2024 KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx ... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 18, 2024 A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-enc... The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge... Class II Polymer Technology Systems, Inc. dba PTS Diagno...
Sep 17, 2024 Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in mi... A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in ... Class II Zimmer, Inc.
Sep 16, 2024 Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Or... Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complain... Class II Cook Incorporated
Aug 15, 2024 Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-I... Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 40... Class II Roche Diagnostics Operations, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in th... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Jul 2, 2024 CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip... Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). T... Class II Zimmer, Inc.
May 17, 2024 RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hi... 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to jo... Class II Biomet, Inc.
May 15, 2024 Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 15, 2024 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 13, 2024 Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg... Class II Roche Diabetes Care, Inc.
Apr 12, 2024 APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used w... Screw is 16mm long instead of 22mm long. Class II Medartis 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.