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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

Infrastructure

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

1,515 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,515 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 1,515 FDA device recalls.

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DateProductReasonClassFirm
Aug 6, 2015 Neuro Combo Set Case The cases hold surgical instrumentation in place during... The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user withou... Class II Biomet Microfixation, LLC
Aug 5, 2015 Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cer... Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. Class II Biomet Spine, LLC
Jul 29, 2015 UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous de... MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexe... Class II Biomet 3i, LLC
Jul 28, 2015 Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. The device was assembled without screw hole plugs. Class II Biomet, Inc.
Jul 22, 2015 Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Mod... Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft in... Class II Biomet Spine, LLC
Jun 17, 2015 A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surg... Class II Biomet, Inc.
Jun 4, 2015 A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. Class II Biomet, Inc.
Jun 4, 2015 A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedi... The thread location on one of the thread holes is offset from the axis of the predrill hole. The ... Class II Biomet, Inc.
Jun 3, 2015 Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill gui... Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an i... Class II Biomet, Inc.
Jun 3, 2015 Gentle Threads Interference Screw 10x25mm Round Head. An interference fixa... Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed wit... Class II Biomet, Inc.
Jun 3, 2015 Gentle Threads Interference Screw 9x35mm Full Thread. An interference fix... Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed wit... Class II Biomet, Inc.
May 14, 2015 The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Opti... The pin which maintains the knob button, may disconnect and become lost. This may result in a de... Class II BIOMET FRANCE S.A.R.L.
May 1, 2015 Unilateral external fixation ankle clamp Product Usage: Unilateral extern... Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. Thi... Class II Biomet, Inc.
Apr 22, 2015 Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. The Left and Right orientation of the trial was incorrectly etched on one side. When the instrum... Class II Biomet, Inc.
Apr 16, 2015 MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; T... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM M... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
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 12, 2015 Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxia... Multiaxial screws may not meet internal requirements related to fatigue strength. Compression te... Class II Biomet Spine, LLC
Mar 12, 2015 Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usa... Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/... Class II Biomet Spine, LLC
Mar 12, 2015 Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Us... Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/... Class II Biomet Spine, LLC
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.
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 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 7, 2014 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm ... Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis... Class II Biomet 3i, LLC
Nov 7, 2014 OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants. Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis... Class II Biomet 3i, LLC
Nov 7, 2014 OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental ... Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis... Class II Biomet 3i, LLC
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 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand R... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand R... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Re... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Rec... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Rec... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand R... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Sep 26, 2014 Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments ar... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, Inc.
Sep 26, 2014 Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instrume... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, Inc.
Sep 26, 2014 Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments ar... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, 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.