Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 24, 2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74... | Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... | Class II | Terumo Cardiovascular Systems Corp |
| Aug 24, 2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/... | Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... | Class II | Terumo Cardiovascular Systems Corp |
| Aug 24, 2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74... | Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... | Class II | Terumo Cardiovascular Systems Corp |
| Aug 24, 2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25R... | Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... | Class II | Terumo Cardiovascular Systems Corp |
| Aug 24, 2015 | Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo ... | Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... | Class II | Terumo Cardiovascular Systems Corp |
| Aug 24, 2015 | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal sc... | It would be possible for an abnormal analytical test result value from an affected newborn to be ... | Class II | Perkin Elmer Life Sciences Inc |
| Aug 24, 2015 | Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Br... | Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot nu... | Class II | STERILMED, INC. |
| Aug 24, 2015 | Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude... | Potential breach of the sterile barrier packaging. | Class II | C.R. Bard, Inc. |
| Aug 24, 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number... | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 21, 2015 | Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with th... | Overheating and burning of the wire insulation inside the applicator. | Class II | DJO, LLC |
| Aug 21, 2015 | EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscop... | Insufficient information for specific cleaning accessories used for the cleaning and reprocessing... | Class II | Olympus Corporation of the Americas |
| Aug 21, 2015 | Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Univer... | Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to t... | Class II | Integra LifeSciences Corp. |
| Aug 20, 2015 | Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous ... | Two isolated instances of holes in the outer header bag component of the double barrier sterile p... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Aug 19, 2015 | Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. U... | Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... | Class II | Resource Optimization & Innovation Llc |
| Aug 19, 2015 | CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packag... | The wrist straps used for positioning the patient are too long | Class II | Med Tec Inc |
| Aug 19, 2015 | Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF... | One Distal Access Catheter intended for distribution in Korea, was found at a US location. | Class II | Concentric Medical Inc |
| Aug 19, 2015 | ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Mode... | The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 19, 2015 | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:2... | Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulati... | Class II | Covidien LLC |
| Aug 19, 2015 | Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG ... | Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... | Class II | Resource Optimization & Innovation Llc |
| Aug 19, 2015 | Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Prec... | Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulati... | Class II | Covidien LLC |
| Aug 19, 2015 | MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsteril... | Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulati... | Class II | Covidien LLC |
| Aug 18, 2015 | Actifuse ABX/Actifuse MIS System A bone void filler intended only for ort... | Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS Sys... | Class II | Apatech Limited |
| Aug 18, 2015 | MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist ... | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... | Class II | Medtronic Perfusion Systems |
| Aug 18, 2015 | PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cu... | Cracks were discovered in the PET tray of a small population of sterile product. These cracks cre... | Class II | Zien Medical Technologies, Inc |
| Aug 18, 2015 | Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-10... | The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the ... | Class II | Ecolab Inc |
| Aug 18, 2015 | Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid... | Some devices exhibit backup VVI operation due to a backup reset. | Class II | St Jude Medical Cardiac Rhythm Management Division |
| Aug 18, 2015 | Disposable Reflective Marker Spheres The Disposable Reflective Marker Sphe... | Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS... | Class II | Brainlab AG |
| Aug 18, 2015 | MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators... | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... | Class II | Medtronic Perfusion Systems |
| Aug 18, 2015 | SOMATOM Force; computed tomography x-ray system. Intended to generate and ... | Software and firmware bugs | Class II | Siemens Medical Solutions USA, Inc |
| Aug 17, 2015 | CIOS ALPHA; image intensified fluoroscopic x-ray system | patient procedure interruption due to a potential system failure | Class II | Siemens Medical Solutions USA, Inc |
| Aug 17, 2015 | Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacture... | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Pa... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Aug 17, 2015 | da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 ... | Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System ... | Class II | Intuitive Surgical, Inc. |
| Aug 17, 2015 | Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Ma... | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Pa... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Aug 14, 2015 | SOMATOM Definition Flash; intended to produce cross-sectional images of the b... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR ... | The dimensions of the mating features of the recalled products are out of specification causing t... | Class II | Limacorporate S.p.A |
| Aug 14, 2015 | SOMATOM Definition AS, intended to produce cross-sectional images of the body... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition Edge; intended to produce cross-sectional images of the bo... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems | When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose m... | Class II | Toshiba American Medical Systems Inc |
| Aug 14, 2015 | SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoul... | The dimensions of the mating features of the recalled products are out of specification causing t... | Class II | Limacorporate S.p.A |
| Aug 13, 2015 | Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood... | Some 1 1/4" needles were packaged and labeled in the 1" blister package. | Class II | Nipro Medical Corporation |
| Aug 12, 2015 | Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufactur... | Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to is... | Class II | Otto Bock Healthcare Product |
| Aug 12, 2015 | XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z... | The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes ... | Class II | Revmedx Inc |
| Aug 12, 2015 | FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter:... | The expiration date was incorrectly printed on the pouch/box labels of 19 products that were ship... | Class III | Abbott Electrophysiology |
| Aug 11, 2015 | Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm;... | DLS pin breakage during planned implant removal, after uneventful and successful healing of the f... | Class II | Synthes (USA) Products LLC |
| Aug 11, 2015 | Syngo RT Oncologist, an optional accessory to the linear accelerator system a... | This update is intended to provide a software update for the Syngo RT Oncologist, which is curren... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 11, 2015 | Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PA... | Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... | Class II | GE Healthcare |
| Aug 11, 2015 | LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue... | Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports... | Class II | Alcon Research, Ltd. |
| Aug 11, 2015 | Alcon 23G and 25G Valved Entry System provides access into the posterior segm... | The product has potential to leak beyond their design specification. | Class II | Alcon Research, Ltd. |
| Aug 11, 2015 | Custom Paks containing 23G and 25G valved trocar cannula provide access into ... | The product has potential to leak beyond their design specification. | Class II | Alcon Research, Ltd. |
| Aug 11, 2015 | 23G and 25G Constellation Totalplus Paks provides access into the posterior s... | The product has potential to leak beyond their design specification. | Class II | Alcon Research, Ltd. |
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.