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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 6, 2013 | BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 2... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in carton... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog #... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 6, 2013 | BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled... | Microbiological identification media may exhibit reduced levels of Vancomycin. | Class II | Becton Dickinson & Co. |
| Jun 5, 2013 | 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Cro... | 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 cont... | Class III | 3M Company - Health Care Business |
| Jun 4, 2013 | Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in d... | Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently deter... | Class II | Mesa Laboratories, Inc., Bozeman Manufacturing ... |
| Jun 4, 2013 | Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended fo... | Self-contained steam biological indicator, are recalled because Mesa recently determined that the... | Class II | Mesa Laboratories, Inc., Bozeman Manufacturing ... |
| Jun 3, 2013 | Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O... | Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the spon... | Class II | Alere San Diego, Inc. |
| Jun 3, 2013 | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the ... | As a result of a quality review, labelling content discrepancies were identified between the Inst... | Class III | Integra LifeSciences Corp. |
| May 31, 2013 | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, use... | Electrical power module installed on some in vitro diagnostic instruments does not meet industry ... | Class III | Becton Dickinson & Co. |
| May 31, 2013 | Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting... | The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column ... | Class II | Synthes (USA) Products LLC |
| May 30, 2013 | Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Use... | Medical devices were incorrectly labeled with extended expiration dates. | Class II | Terumo Medical Corporation |
| May 30, 2013 | Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Ti... | Medical devices were incorrectly labeled with extended expiration dates. | Class II | Terumo Medical Corporation |
| May 28, 2013 | Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Materia... | Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch o... | Class II | Boston Scientific Corporation |
| May 28, 2013 | BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm... | Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of dev... | Class II | Bard Peripheral Vascular Inc |
| May 28, 2013 | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00... | Product labeled with incorrect expiration date. | Class III | Boston Scientific Corporation |
| May 24, 2013 | AMICUS Exchange Kit; Product Usage: This kit is designed for use with th... | Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339... | Class II | Fenwal Inc |
| May 16, 2013 | Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound... | Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user... | Class II | U-systems Inc |
| May 13, 2013 | Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of... | Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2... | Class II | Coloplast Manufacturing US, LLC |
| May 10, 2013 | Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) | A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... | Class II | Biomet 3i, LLC |
| May 10, 2013 | Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (... | A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... | Class II | Biomet 3i, LLC |
| May 6, 2013 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Multiple studies were missing at a customer location that never made it to the archive before wat... | Class II | Merge Healthcare, Inc. |
| May 2, 2013 | Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal groupin... | The product may give weak or false negative test results. | Class II | Remel Inc |
| May 2, 2013 | Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal g... | The product may give weak or false negative test results. | Class II | Remel Inc |
| May 1, 2013 | CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421... | Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification | Class II | CooperSurgical, Inc. |
| Apr 30, 2013 | AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following ... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Apr 30, 2013 | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioD... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Apr 26, 2013 | Active Articulation E1. Intended for use with either primary or revision h... | Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this actio... | Class II | Biomet, Inc. |
| Apr 22, 2013 | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Bi... | Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indi... | Class II | Advanced Sterilization Products |
| Apr 17, 2013 | Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube use... | The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. | Class I | Bryan Medical Inc |
| Apr 15, 2013 | Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synth... | Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive ... | Class II | Synthes USA HQ, Inc. |
| Apr 15, 2013 | DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusab... | Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Apr 12, 2013 | Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Colopla... | Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorre... | Class II | Coloplast Manufacturing US, LLC |
| Apr 12, 2013 | Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitr... | Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pur... | Class II | Paa Laboratories Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, ... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, pa... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, ... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, p... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 4, 2013 | remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-... | The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislab... | Class II | Remel Inc |
| Apr 4, 2013 | ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in t... | Expiration date on the patient label and date on the product carton were not the same. | Class II | Medshape Solutions, INC. |
| Apr 2, 2013 | Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc.... | Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors in... | Class II | Synvasive Technology Inc |
| Apr 1, 2013 | 3DKnee e+ Tibial Insert. The insert is used along with the other components t... | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels... | Class II | Encore Medical, Lp |
| Mar 29, 2013 | Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466... | Correction to provide clarification and additional labeling to minimize likelihood on implanting ... | Class I | Cordis Corporation |
| Mar 28, 2013 | The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analy... | 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellit... | Class III | Abbott Molecular |
| Mar 25, 2013 | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT... | Use of affected lots may give false indication of susceptibility to Nitrofurantoin. | Class III | Remel Inc |
| Mar 25, 2013 | Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit pe... | Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathal... | Class II | Stryker Howmedica Osteonics Corp. |
| Mar 25, 2013 | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(... | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner labe... | Class III | Microbiologics Inc |
| Mar 22, 2013 | LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
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.