Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M003168191... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Prod... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is ... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product i... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M003168190... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Pro... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product i... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Produ... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Pro... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 ... The patient label associated with the product may be incorrect in that the lot number on the pati... Class II Zimmer, Inc.
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 1, 2013 Acetabular Pressurizer; single use and six units per box. The Acetabular P... On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer ... Class II Stryker Instruments Div. of Stryker Corporation
Oct 30, 2013 Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #... The lift might fail with the labeled 500-lb. load rating. Class II Ergosafe Products LLC DBA Prism Medical Service...
Oct 30, 2013 Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. ... The lift might fail with the labeled 500-lb. load rating. Class II Ergosafe Products LLC DBA Prism Medical Service...
Oct 29, 2013 Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Ac... Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated... Class II Kimberly-Clark Corporation
Oct 28, 2013 Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product cont... Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber ba... Class II Centurion Medical Products Corporation
Oct 25, 2013 *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE ... Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assemb... Class II Hospira Inc.
Oct 23, 2013 Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette,... Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-99... Class III Alere San Diego, Inc.
Oct 23, 2013 Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gel... Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm... Class II Terumo Cardiovascular Systems Corporation
Oct 17, 2013 Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief,... Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol. Class II GlaxoSmithKline, LLC.
Oct 15, 2013 Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upp... Labeling inconsistency Class II Teleflex Medical
Oct 11, 2013 BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tube... An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in u... Class II Becton Dickinson & Co.
Oct 10, 2013 Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro... A review of complaints identified a trend for drills breaking. Class II Cayenne Medical Inc.
Oct 9, 2013 Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is use... A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Oste... Class II Synthes USA HQ, Inc.
Oct 9, 2013 Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripher... A labeling inconsistency was discovered in which the lidstock states that the kit contains a stim... Class II Arrow International Inc
Oct 7, 2013 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on... In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the p... Class II Baxter Healthcare Corp.
Oct 7, 2013 C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12... As the result of a recent internal review of regulatory documents, we have determined that the 10... Class II RTI Surgical, Inc.
Oct 3, 2013 Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be... During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as S... Class II Synthes USA HQ, Inc.
Oct 3, 2013 ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bo... Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitut... Class III Biomet 3i, LLC
Sep 27, 2013 OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-US... Alcohol Prep Pads contained within the kit are not properly labeled. Class II Insulet Corporation
Sep 27, 2013 OmniPod Insulin Management Product Demonstration Kit; Model Reference Number:... Alcohol Prep Pads contained within the kit are not properly labeled. Class II Insulet Corporation
Sep 26, 2013 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics ... The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marke... Class II OrthoPediatrics Corp
Sep 25, 2013 Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corp... Incomplete foil seal on one lot of sterile product. Class II Baxter Healthcare Corp.
Sep 23, 2013 Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont... Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN ... Class III Alere San Diego, Inc.
Sep 20, 2013 Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa... Product mix occurred prior to final package and labeling process. Class II Biomet Microfixation, LLC
Sep 20, 2013 Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use d... MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D).... Class II Maquet Cardiovascular, LLC
Sep 19, 2013 Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology ... Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Te... Class I Atossa Genetics, Inc.
Sep 18, 2013 STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperat... Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRA... Class II Advanced Sterilization Products
Sep 18, 2013 Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; V... Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporizat... Class II Richard Wolf Medical Instruments Corp.
Sep 16, 2013 NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the ... Class II Medtronic Vascular, Inc.
Sep 13, 2013 NX3 Try-In Gel. The product is used as a tooth shade resin material. Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-... Class II Kerr/Pentron, DBA Kerr Corporation and Pentron ...

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.