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 |
|---|---|---|---|---|
| Jul 19, 2013 | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access an... | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Class II | Instrumentation Laboratory Co. |
| Jul 19, 2013 | C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue de... | Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... | Class II | Atrium Medical Corporation |
| Jul 18, 2013 | Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late... | Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sa... | Class II | Aspen Surgical Products, Inc. |
| Jul 18, 2013 | Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 un... | GE Healthcare has become aware of a potential safety issue associated with the use of GE General ... | Class II | Vital Signs Devices, a GE Healthcare Company |
| Jul 18, 2013 | PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/... | Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 17, 2013 | Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalo... | Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due ... | Class II | Arrow International Inc |
| Jul 17, 2013 | Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually r... | Beckman Coulter has received a customer complaint that suggests trending of positive results has... | Class II | Beckman Coulter Inc. |
| Jul 17, 2013 | Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 90... | Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System... | Class II | Hospira Inc. |
| Jul 17, 2013 | Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Cat... | The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW... | Class II | Arrow International Inc |
| Jul 17, 2013 | Medtronic Custom Perfusion System with Trillium BioSurface (a polymer contain... | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 17, 2013 | Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1... | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 17, 2013 | Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hard... | As a result of complaint investigations it was identified that there is a potential that the Leyl... | Class II | Integra Limited |
| Jul 17, 2013 | Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numb... | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: ... | Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were buil... | Class II | Edwards Lifesciences, LLC |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200... | Individual component's IFUs are not included with the kit. | Class II | Atrium Medical Corporation |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, p... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA el... | The products may have been stored at temperatures outside their required storage conditions. | Class II | Assuramed |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to com... | The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose ... | Class II | Brainlab AG |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Ste... | Zimmer recently conducted a review of historic packaging validations completed. Based on this re... | Class II | Zimmer, Inc. |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, ... | HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Al... | Class II | HemoCue AB |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store ... | The products may have been stored at temperatures outside their required storage conditions. | Class II | Assuramed |
| Jul 16, 2013 | Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (... | Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ... | Class III | Zoll Circulation, Inc. |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality... | The products may have been stored at temperatures outside their required storage conditions. | Class II | Assuramed |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical inst... | Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially e... | Class II | Aesculap, Inc. |
| Jul 16, 2013 | Brilliance iCT and Brilliance iCT SP These systems are intended to produce... | An artifact that resembles thrombus may appear on the image. | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 15, 2013 | Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy Syste... | Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). Fo... | Class II | China Daheng Group Inc. |
| Jul 15, 2013 | Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable C... | Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to... | Class II | Boston Scientific CRM Corp |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Prod... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Produ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
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.