Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 20, 2013 | Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a var... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a v... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 19, 2013 | Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopul... | Potential for uncharacteristically rough metal edges to occur along the inner diameter of the met... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Feb 19, 2013 | Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of ... | WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock... | Class II | Tecan US, Inc. |
| Feb 19, 2013 | Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free ... | Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch ... | Class II | Hospira Inc. |
| Feb 19, 2013 | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003... | Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with t... | Class III | Remel Inc |
| Feb 19, 2013 | Helion S Exam Light or H300 The device is intended to locally illuminate a... | Possible fatigue failure of the plastic joint may occur after an average use of seven years. | Class II | Trumpf Medical Systems, Inc. |
| Feb 18, 2013 | Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 1... | A software defect was discovered that causes images to be out of context with clinical information. | Class II | Ge Healthcare It |
| Feb 18, 2013 | Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solut... | It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging... | Class II | Ge Medical Systems Information T |
| Feb 18, 2013 | The Centricity PACS Workstation is intended for use as a primary diagnostic a... | Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Se... | Class II | GE Healthcare |
| Feb 18, 2013 | VITEK 2 Compact computer system when equipped with the following Hewlett-Pack... | There is a potential to link an isolate result to the wrong patient and then upload the results t... | Class II | Biomerieux Inc |
| Feb 18, 2013 | VITEK 2 XL computer system when equipped with the following Hewlett-Packard P... | There is a potential to link an isolate result to the wrong patient and then upload the results t... | Class II | Biomerieux Inc |
| Feb 18, 2013 | Punch Hair Matic A surgical hair transplant device designed for automation... | Medicamat is initiating a field correction due to misbranded marketing literature for the Punch H... | Class II | MEDICAMAT S.A. |
| Feb 18, 2013 | VITEK 2 60 computer system when equipped with the following Hewlett-Packard P... | There is a potential to link an isolate result to the wrong patient and then upload the results t... | Class II | Biomerieux Inc |
| Feb 15, 2013 | Molift Smart 150 | The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user. | Class II | Moller Vital |
| Feb 15, 2013 | Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brillian... | This field change order is being released to update software and customer release notes to the af... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 15, 2013 | Molift Smart 150 | The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user. | Class II | Moller Vital |
| Feb 15, 2013 | RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0... | Under some circumstances, imported CT, MR and PET images are offset from their true positions by ... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 15, 2013 | PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Inten... | Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials. | Class II | Unimed Surgical Products, Inc. |
| Feb 15, 2013 | ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management ... | Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrec... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Feb 14, 2013 | Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter ass... | The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting b... | Class II | Zimmer, Inc. |
| Feb 14, 2013 | Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to ai... | Distribution of an unapproved device into interstate commerce. | Class II | Elana, Inc. |
| Feb 14, 2013 | BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 m... | The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags whic... | Class III | Becton Dickinson & Company |
| Feb 12, 2013 | AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat an... | The control boards alarm set points and temperature tolerances allowed for erroneous activation ... | Class II | Steris Corporation |
| Feb 12, 2013 | Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., Intel... | Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 12, 2013 | Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, ... | Out of specification result - stability test failure of free available chlorine (FAC) which funct... | Class II | Oculus Innovative Sciences Inc |
| Feb 12, 2013 | Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access... | Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... | Class II | Beckman Coulter Inc. |
| Feb 12, 2013 | UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage... | Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... | Class II | Beckman Coulter Inc. |
| Feb 12, 2013 | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. ... | The test strips in the affected product lots of the OC Light immunological fecal occult blood tes... | Class II | Polymedco, Inc |
| Feb 12, 2013 | Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Syste... | Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... | Class II | Beckman Coulter Inc. |
| Feb 12, 2013 | Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in ... | Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions alrea... | Class II | Integra LifeSciences Corp. |
| Feb 12, 2013 | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. ... | The test strips in the affected product lots of the OC Light immunological fecal occult blood tes... | Class II | Polymedco, Inc |
| Feb 12, 2013 | Access Immunoassay System; P/N 107405S Product Usage: The Access Immu... | Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... | Class II | Beckman Coulter Inc. |
| Feb 11, 2013 | Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC My... | Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL... | Class II | Microbiologics Inc |
| Feb 11, 2013 | Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm ... | Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in d... | Class II | Covidien LP |
| Feb 11, 2013 | ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 12096... | Multiple incidents of low-reacting assay plates. | Class II | Innominata Dba Genbio |
| Feb 11, 2013 | Monaco RTP System. Radiation treatment planning. | The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" a... | Class II | Elekta, Inc. |
| Feb 10, 2013 | ROSA Surgical Device 2.5.8 | Issue with optional neuro-endoscopy module detected under specific conditions during internal tes... | Class II | Zimmer Biomet, Inc. |
| Feb 8, 2013 | The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbe... | LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to t... | Class II | Physio Control, Inc. |
| Feb 8, 2013 | BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, R... | Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay ... | Class II | Becton Dickinson & Co. |
| Feb 8, 2013 | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Ave... | Orthodontic brackets distributed was incorrectly labeled. | Class III | Ultradent Products, Inc. |
| Feb 8, 2013 | GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ ... | GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe us... | Class II | GE Healthcare, LLC |
| Feb 8, 2013 | Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, ... | There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... | Class I | Medtronic Neuromodulation |
| Feb 8, 2013 | Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. S... | There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... | Class I | Medtronic Neuromodulation |
| Feb 8, 2013 | Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part ... | Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a s... | Class II | Zimmer, Inc. |
| Feb 7, 2013 | VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemis... | Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems ... | Class II | Ortho-Clinical Diagnostics |
| Feb 7, 2013 | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAP... | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre... | Class II | Smith & Nephew Inc |
| Feb 7, 2013 | Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-50017... | Increased risk of failure at the driver tip during screw insertion or removal. | Class II | Ebi, Llc |
| Feb 7, 2013 | CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 4... | The cassettes were shipped with the wrong IP (image plate) size bar code. | Class II | AGFA Corp. |
| Feb 7, 2013 | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAP... | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre... | Class II | Smith & Nephew 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.