Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

2,527 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,527 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 2,527 FDA device recalls in IN.

Clear
DateProductReasonClassFirm
Feb 15, 2023 Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Nu... The subject product lots are being recalled because they received a higher than specified irradia... Class II DePuy Orthopaedics, Inc.
Feb 15, 2023 Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part ... The subject product lots are being recalled because they received a higher than specified irradia... Class II DePuy Orthopaedics, Inc.
Feb 6, 2023 G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Nu... The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 3... Class II Biomet, Inc.
Feb 3, 2023 Med-Riser MR600 Patient Lift Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be uns... Class II Med-Mizer, Inc.
Feb 3, 2023 Sit to Stand STS500 Patient Lift Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be uns... Class II Med-Mizer, Inc.
Jan 4, 2023 WishBone Medical Smart Correction Dual Joint Express Struts, external skeleto... Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint E... Class II Wishbone Medical, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Kne... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 15, 2022 Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to repla... Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than th... Class II Biomet, Inc.
Dec 12, 2022 cobas infinity central lab, Material Number 07154003001 A complaint investigation revealed that an incorrect behavior relating to the rejection of orders... Class II Roche Diagnostics Operations, Inc.
Dec 7, 2022 Identity Shoulder System Resection Planer 35mm Resection Planer Two planers were found to be unusable during sawbones shoulder training. Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Nov 29, 2022 OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For... Product missing the four small locking collar bolts resulting in extension of surgery to find a r... Class II Biomet, Inc.
Sep 12, 2022 Orthex Large Bone Shoulder Bolt, model no. AS-17 Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with fram... Class II OrthoPediatrics Corp
Aug 25, 2022 G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 ... The outer sterile package cavity has a corner wall thickness that is below the specification. The... Class II Zimmer, Inc.
Aug 16, 2022 Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFS... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 PTS Panels CHOL+GLU Test Strips (REF 1765) Incorrect instructions for use were packaged into the final product. Class III Polymer Technology Systems, Inc. dba PTS Diagno...
Aug 16, 2022 Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Par... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-14... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN TH... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; R... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RP... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part N... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Numbe... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Referen... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part N... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN ... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Pa... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated

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.