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Vehicle Safety

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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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
Mar 18, 2015 LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Pro... A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number... Class II Biomet, Inc.
Mar 10, 2015 Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Person... Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking ... Class II Zimmer, Inc.
Mar 4, 2015 LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prost... The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patell... Class II DePuy Orthopaedics, Inc.
Mar 4, 2015 LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthop... The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patell... Class II DePuy Orthopaedics, Inc.
Mar 2, 2015 Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece. The metal cannula attached to the handpiece can rotate and become dislodged from the plastic hand... Class II Hill-Rom, Inc.
Feb 26, 2015 ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligame... The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... Class II Biomet, Inc.
Feb 26, 2015 Ziploop Button Product Usage: The Ziploop Button is a non-resorbable syst... The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... Class II Biomet, Inc.
Feb 23, 2015 RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instru... This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery... Class II DePuy Orthopaedics, Inc.
Feb 17, 2015 Double Swivel Connector with Suction Port Connector, Airway (Extension) Kin... Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel ... Class II King Systems Corp.
Feb 11, 2015 SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl m... One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in sur... Class II DePuy Orthopaedics, Inc.
Feb 5, 2015 Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem ... PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. Class II Zimmer, Inc.
Jan 28, 2015 Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Pa... An increase in complaints of loosening and radiolucent lines. Class II Zimmer, Inc.
Jan 9, 2015 Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... Class II Biomet, Inc.
Jan 9, 2015 Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis co... Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... Class II Biomet, Inc.
Jan 7, 2015 Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Ada... The taper adaptor is missing from the packaging, which may result in a delay in surgery greater t... Class II Biomet, Inc.
Dec 18, 2014 Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positi... Class II Roche Diagnostics Operations, Inc.
Dec 11, 2014 Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots ... Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of s... Class II Zimmer, Inc.
Dec 8, 2014 Osteobond Bone Cement Bone cement monomer is kitted with bone cement powde... Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between ... Class II Zimmer, Inc.
Dec 4, 2014 Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Ti... The affected lot was supplied by contract manufacturer and are potentially subject to disassociat... Class II Zimmer, Inc.
Dec 2, 2014 Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identi... After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... Class II Biomet, Inc.
Dec 2, 2014 Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Nam... After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... Class II Biomet, Inc.
Nov 25, 2014 Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Ma... Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x ... Class II Zimmer, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the ... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infus... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusi... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the ... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infus... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the ... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for t... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusi... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the ... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusi... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 12, 2014 I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. ... Use of excessive force when impacting may lead to intra-operative femoral fracture. Class II DePuy Orthopaedics, Inc.
Nov 10, 2014 Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors a... ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... Class II DePuy Orthopaedics, Inc.
Nov 10, 2014 The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in ... Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during i... Class II DePuy Orthopaedics, Inc.
Nov 10, 2014 Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Imp... ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... Class II DePuy Orthopaedics, Inc.
Nov 10, 2014 Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactor... ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... Class II DePuy Orthopaedics, Inc.
Nov 7, 2014 Ceramic Femoral Head. Intended for use in total hip arthroplasty applica... Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (... Class II DePuy Orthopaedics, Inc.
Nov 6, 2014 ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to gu... Potential failure of a force feedback sensor that may result in continued movement of an operatin... Class II Zimmer Biomet, Inc.
Oct 30, 2014 ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to ... Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management a... Class II Roche Diabetes Care, Inc.
Oct 15, 2014 ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in ... Issuing a device correction because if the pin bushing is over loaded or inverted, there is the p... Class II DePuy Orthopaedics, Inc.
Oct 14, 2014 Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads ... To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal T... Class II Zimmer, Inc.
Oct 14, 2014 Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibi... To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal T... Class II Zimmer, Inc.
Oct 9, 2014 Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is i... Cleaning process validation failure. Class II Zimmer, Inc.
Oct 7, 2014 The Persona Tibial Articular Surface Inserter is a sterilizable instrument in... Affected product did not undergo heat treatment hardening step leading to the potential for defor... Class II Zimmer, Inc.
Oct 2, 2014 Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in ... Failed to meet established requirements for sterile barrier integrity due to a breach of the inne... Class II Zimmer, Inc.
Oct 1, 2014 Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 6... The affected products are missing polar boss threads. Class II Zimmer, Inc.
Sep 26, 2014 Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set ... MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by ... Class II Cook Medical 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.