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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

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Oct 10, 2019 NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 0058500... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 4724931801... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 4723571... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107 Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 0023470030... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 LPS-MOB ART SURF IMPL D 9MM Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various fixation systems and accessories, Item Nos. 00224000916 00224000918 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various fixation systems and accessories, Item Nos. 00118100522 00118100527 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 008... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various temporary devices used during the implantation of the device system: ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 008... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 328554... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Connection Screw for NCB Plate, Item No. 0202266002 Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 004300007... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 9, 2019 Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V A... The firm has identified that packaging containing components of the hip replacement range are mi... Class II Signature Orthopaedics Europe Ltd
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 7, 2019 NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545... There is a remote potential for the sterile packaging of the transseptal guiding sheath to be com... Class II Baylis Medical Company Inc.
Oct 7, 2019 TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-5... There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath t... Class II Baylis Medical Company Inc.
Oct 3, 2019 Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave... One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier... Class II Datascope Corp.
Oct 1, 2019 Aesculap Sterile disposable fleece drape, Product code: GA414, individually p... Packaging seal integrity not validated resulting in a lack of sterility assurance. Class II Aesculap Implant Systems LLC
Sep 12, 2019 Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is t... labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the in... Class II Merit Medical Systems, Inc.
Aug 30, 2019 SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G... Problem with packaging sealing process which affects sterility. Class II Pajunk GmbH
Aug 28, 2019 NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); R... The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implan... Class II Nobel Biocare Usa Llc
Aug 22, 2019 iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient... Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. Class II Conformis, Inc.
Aug 22, 2019 iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient... Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. Class II Conformis, Inc.
Aug 21, 2019 Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthop... Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the... Class II Zimmer GmbH
Aug 14, 2019 Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40... The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended ... Class II Bard Peripheral Vascular Inc
Aug 9, 2019 Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... Samples in the identified lot were found to have incomplete or open packaging seals. Class II Medline Industries Inc
Jul 24, 2019 The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a late... incorrect device size being listed on the impacted device packaging Class II LeMaitre Vascular, Inc.
Jul 1, 2019 STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used ... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for perform... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driv... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used f... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used f... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regio... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for lac... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceratio... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:Th... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation

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.