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

317 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 317 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 317 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 24, 2017 rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of ... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replac... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 #4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 radial stem implant #2 (Sterile packed). Orthopedic implant for replacement ... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of ... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for repl... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the prox... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 #3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 #1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacemen... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Radio Capitellum Large, Right. Orthopedic implant for replacement of the pro... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replace... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for r... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 radial stem implant #1 (Sterile packed). Orthopedic implant for replacement ... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replac... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for r... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for repl... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for repl... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacem... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for r... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 Radio Capitellum Small, Left. Orthopedic implant for replacement of the prox... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Oct 24, 2017 radial stem implant #3 (Sterile packed). Orthopedic implant for replacement ... Revision rate identified as higher than other proximal radial head replacement devices based on l... Class II Howmedica Osteonics Corp.
Sep 8, 2017 AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the ... When the lever of the Insertion Handle is in the "locked" position, the implant may be able to p... Class II Howmedica Osteonics Corp.
Jul 21, 2017 Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, ... Inner and outer sterile barriers not fully sealed. Class II Howmedica Osteonics Corp.
Jul 21, 2017 Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737 Inner and outer sterile barriers not fully sealed. Class II Howmedica Osteonics Corp.
Apr 26, 2017 Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-4... Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport... Class II Stryker Howmedica Osteonics Corp.
Dec 2, 2016 Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound... Reunion TSA Peg Alignment Sound broke during surgery. Class II Stryker Howmedica Osteonics Corp.
Nov 9, 2016 GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stry... A review of packaging revealed the seal integrity of the pouch may be compromised. More specifica... Class II Stryker Howmedica Osteonics Corp.
Aug 29, 2016 LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, R... Stryker received several complaints describing incidence of harm secondary to taper lock failure ... Class II Stryker Howmedica Osteonics Corp.
Aug 18, 2016 Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0... Stryker Orthopaedics has received reports of the thread length protruding past the dome of the ac... Class II Stryker Howmedica Osteonics Corp.
Aug 1, 2016 Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile,... Upon failure of the press-fit, the clamping sub components and pins could disassociate from the S... Class II Stryker Howmedica Osteonics Corp.
Jul 26, 2016 AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLI... Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... Class II Howmedica Osteonics Corp.
Jul 26, 2016 AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The Accu... Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... Class II Howmedica Osteonics Corp.
Jul 26, 2016 AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuL... Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... Class II Howmedica Osteonics Corp.
Jul 1, 2016 Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reus... Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 23, 2016 Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6... Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis reveal... Class II Stryker Howmedica Osteonics Corp.
Jun 23, 2016 Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Seconda... It was reported that the secondary locking mechanism, and its corresponding components, disassoci... Class II Stryker Howmedica Osteonics Corp.
Jun 3, 2016 Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, ... Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recomme... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporar... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intend... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temp... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary st... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.

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.