Browse Device Recalls
1,040 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,040 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 1,040 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 6, 2014 | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter... | Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce... | Class III | Siemens Healthcare Diagnostics, Inc |
| Sep 30, 2014 | CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Mode... | Incorrect expiration date printed on the MILEX PESSARY KIT packaging | Class III | CooperSurgical, Inc. |
| Sep 30, 2014 | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: ... | Incorrect expiration date printed on the MILEX PESSARY KIT packaging | Class III | CooperSurgical, Inc. |
| Sep 29, 2014 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis... | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod... | Class III | Ortho-Clinical Diagnostics |
| Sep 17, 2014 | ProClear Toric contact lenses are made from a material containing 62%... | Routine quality monitoring system has identified that a limited number of lots were manufactured... | Class III | Cooper Vision Caribbean Corp. |
| Sep 12, 2014 | Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roch... | The default references for normal values are inconsistent between cobas b 221 and other blood gas... | Class III | Roche Diagnostics Operations, Inc. |
| Sep 12, 2014 | ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution ... | Stability of the ADVIA Centaur Cleaning Solution is not assured | Class III | Siemens Healthcare Diagnostics, Inc |
| Sep 8, 2014 | Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Cou... | Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound d... | Class III | Coloplast Manufacturing US, LLC |
| Aug 13, 2014 | JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument ... | BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because th... | Class III | Biofire Defense |
| Aug 11, 2014 | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. ... | Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing tha... | Class III | ELITech Clinical Systems SAS |
| Aug 11, 2014 | LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group | During label reconciliation a duplicate serial number label was detected to be printed for the LI... | Class III | Datascope Corporation |
| Jul 18, 2014 | Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kit... | Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (sub... | Class III | Diagnostica Stago, Inc. |
| Jul 18, 2014 | BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete ... | The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be ... | Class III | BD Biosciences, Systems & Reagents |
| Jul 16, 2014 | Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355;... | Some sheets of the medical screen film are fogged. | Class III | AGFA Healthcare Corp. |
| Jul 10, 2014 | RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, S... | Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date... | Class III | Teleflex Medical |
| Jul 2, 2014 | INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL... | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... | Class III | Carestream Health Inc. |
| Jul 2, 2014 | Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DE... | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... | Class III | Carestream Health Inc. |
| Jun 30, 2014 | Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: ... | STERIS has identified that deformation of the washers door handle pin may occur when the door ha... | Class III | Steris Corporation |
| May 30, 2014 | Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa... | Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family o... | Class III | Alere San Diego, Inc. |
| May 27, 2014 | Dimension¿ Integrated Chemistry Systems intended to measure a variety of anal... | There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Sy... | Class III | Siemens Healthcare Diagnostics, Inc. |
| May 22, 2014 | Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management ... | RAPIDComm¿ 5.0 Screen Layout will display incorrect test names | Class III | Siemens Healthcare Diagnostics Inc |
| May 21, 2014 | BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catal... | A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 322... | Class III | Becton Dickinson & Co. |
| May 15, 2014 | Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial... | The original mean assigned to the control too high, upon reassignment with additional data the ne... | Class III | Medtest Holdings, Inc. |
| May 13, 2014 | Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicate... | Unit was mislabeled with a factory label showing 32 KW output power. | Class III | AGFA Healthcare Corp. |
| May 13, 2014 | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep... | A limited number of DV5x Series CPAP units were manufactured and shipped without the serial numbe... | Class III | DeVilbiss Healthcare LLC |
| May 1, 2014 | NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with ... | Container cap may contain foreign material- 0.60% - 0.80% Manganese | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 25, 2014 | VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory s... | The keyboard and monitor may not be properly secured to the monitor arm. | Class III | Siemens Medical Solutions Diagnostics |
| Apr 17, 2014 | APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233... | Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collectio... | Class III | Gen-Probe Inc |
| Apr 7, 2014 | PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebr... | The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a compo... | Class III | Laurimed LLC |
| Apr 1, 2014 | NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. | Device has the potential to have torn wings. | Class III | Nipro Medical Corporation |
| Mar 18, 2014 | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists... | Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when ... | Class III | Nanosphere, Inc. |
| Feb 19, 2014 | Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes,... | The bar code that is printed on the Master Carton label does not correspond to the product code f... | Class III | Medefil Incorporated |
| Feb 18, 2014 | Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; I... | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified thro... | Class III | Lin-Zhi International Inc |
| Feb 17, 2014 | TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkst... | If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the ... | Class III | Technidata S.A. |
| Feb 6, 2014 | Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2... | Incorrect master label. | Class III | Medtronic Vascular |
| Jan 27, 2014 | CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-0... | Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return o... | Class III | Cardiovascular Systems, Inc. |
| Jan 15, 2014 | VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATAL... | Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin... | Class III | Ortho-Clinical Diagnostics |
| Dec 18, 2013 | ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-le... | HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine ass... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Dec 11, 2013 | AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identificat... | Kits incompatible with certain fluorescence microscope light sources | Class III | AdvanDx, Inc. |
| Dec 2, 2013 | MAS Omni Immune PRO Controls | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; ho... | Class III | Microgenics Corporation |
| Dec 2, 2013 | MAS Omni Immune Controls | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; ho... | Class III | Microgenics Corporation |
| Nov 22, 2013 | D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. Un... | D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not b... | Class III | Bio-Rad Laboratories, Inc. |
| Nov 20, 2013 | Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straig... | Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scis... | Class III | Edwards Lifesciences, LLC |
| Nov 19, 2013 | Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex... | Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the de... | Class III | Ultradent Products, Inc. |
| Oct 29, 2013 | MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)... | Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet ... | Class III | Thermofisher Scientive |
| 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 21, 2013 | da Vinci Vision System Cart, a component of the da Vinci Si Surgical System ... | Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompati... | Class III | Intuitive Surgical, Inc. |
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.