Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 ... |
| Sep 13, 2013 | Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. T... | Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly l... | Class II | Southern Implants, Inc |
| Sep 10, 2013 | VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STER... | STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM ... | Class II | Steris Corporation |
| Sep 10, 2013 | Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, pack... | Expired active ingredient was used in the manufacture of the product. | Class II | Wexford Labs Inc |
| Sep 10, 2013 | Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Ca... | Integra LifeSciences has identified through an internal evaluation that in order to comply with U... | Class II | Integra Limited |
| Sep 9, 2013 | *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | Class II | Hospira Inc. |
| Sep 9, 2013 | *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBL... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | Class II | Hospira Inc. |
| Sep 9, 2013 | *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BL... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | Class II | Hospira Inc. |
| Sep 9, 2013 | *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH ... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | Class II | Hospira Inc. |
| Sep 9, 2013 | *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE P... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | Class II | Hospira Inc. |
| Sep 9, 2013 | BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, package... | An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on as... | Class II | Becton Dickinson & Co. |
| Sep 4, 2013 | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calc... | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens r... | Class II | SEPPIM SAS |
| Sep 3, 2013 | Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 M... | During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Opera... | Class II | Cincinnati Sub-Zero Products Inc |
| Aug 30, 2013 | CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are us... | CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date.... | Class II | CareFusion 303, Inc. |
| Aug 28, 2013 | *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; **... | Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the corr... | Class II | Hospira Inc. |
| Aug 27, 2013 | H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573... | Medical device tubing used for endotracheal airway application may become weakened and rendered i... | Class I | H & H Associates |
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.