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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

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 9, 2019 Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Thoracentesis Set, RPN C-THS-850, Order # G03286 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 4, 2019 cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to become loose, potent... Class III Roche Diagnostics Corporation
Apr 4, 2019 cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to become loose, potent... Class III Roche Diagnostics Corporation
Apr 1, 2019 Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical interverteb... Incorrect part description contained on an additional label placed on the packaging: A 14mm lengt... Class II Zimmer Biomet, Inc.
Mar 28, 2019 T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Head... There is a potential of fracture, bending or shearing of the driver. Class II Zimmer Biomet, Inc.
Mar 28, 2019 T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet... There is a potential of fracture, bending or shearing of the driver. Class II Zimmer Biomet, Inc.
Mar 18, 2019 Albumin BCP Product Usage: ALBP is an in vitro test used for the quantit... The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due ... Class II Roche Diagnostics Corporation
Mar 15, 2019 cobas e 801 immunoassay analyzer The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCel... Class II Roche Diagnostics Corporation
Mar 1, 2019 Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Tita... Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for th... Class II Zimmer Biomet, Inc.
Mar 1, 2019 Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Tita... Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for th... Class II Zimmer Biomet, Inc.
Feb 28, 2019 Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory inst... Lack of an adequate sterilization validation Class II Zimmer Biomet, Inc.
Feb 25, 2019 Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Ca... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Appro... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 4, 2019 Cobas¿ infinity central lab IT solution Material Number: 07154003001 Ca... Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential ... Class II Roche Diagnostics Corporation
Feb 1, 2019 Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. ... The products were manufactured without a back bevel on the needle tip. This could cause damage to... Class I Cook Inc.
Jan 16, 2019 Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as... Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Jan 16, 2019 Lipid Panel test strips (as a component of smart bundles), REF 2729, also pri... Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Jan 16, 2019 CHOL+HDL+GLU test strips, REF 2412 Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Jan 4, 2019 Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G499... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G1... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 King LTS-D Kit Size 1, Model Number KLTSD431 Size 0 products were incorrectly packaged and labeled as a size 1 products. Class II King Systems Corp. dba Ambu, Inc.
Jan 4, 2019 Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Urethral Dilator Set, Global Product No. G14185 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Wire Guide, Guidewire, Global Product Number G14326 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G1... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G1490... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Cathe... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G498... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook 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.