Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 3, 2014 | Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This dev... | Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a ... | Class II | Shimadzu Medical Systems |
| Apr 3, 2014 | Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spina... | B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing th... | Class II | B. Braun Medical, Inc. |
| Apr 3, 2014 | Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PA... | Systems with the affected serial number are experiencing a software error which may lead to incor... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 3, 2014 | The Centricity PACS Workstation is intended for use as a primary diagnostic a... | It has been identified that in a reject image workflow where multiple studies are simultaneously ... | Class II | GE Healthcare |
| Apr 2, 2014 | GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450... | Potential safety issue with gradient coil electromechanical connections associated with GE MR Pro... | Class II | GE Healthcare, LLC |
| Apr 2, 2014 | Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, ... | When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are use... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 2, 2014 | Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Apr 2, 2014 | Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM pa... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Apr 2, 2014 | Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared ... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Apr 2, 2014 | Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controll... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| Apr 2, 2014 | Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of ... | The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Ge... | Class II | Genesys Orthopedics Systems, LLC |
| Apr 2, 2014 | ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculat... | 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values durin... | Class I | Baxter Corporation Englewood |
| Apr 2, 2014 | Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software appli... | Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density ... | Class II | Philips Medical Systems, Inc. |
| Apr 2, 2014 | Philips HeartStart XL+ Defibrillator/Monitor with system software version B.... | Software communication failure may occur on the HeartStart XL+ locking the user out of clinical m... | Class II | Philips Medical Systems, Inc. |
| Apr 2, 2014 | Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrar... | Medical device software may be defective and may cause user-set alarm limits to result in false p... | Class II | GE Healthcare |
| 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 |
| Apr 1, 2014 | Pipeline Embolization Device (PED). Used endovascular treatment of adults wi... | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delive... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Apr 1, 2014 | 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen de... | After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manu... | Class II | ZOLL Circulation, Inc. |
| Apr 1, 2014 | 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliv... | Table may lose calibration during patient treatment, which may cause the possibility of mistreatm... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 1, 2014 | Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT seri... | A customer reported that the table top had become free floating. A Field Service Engineer (FSE) ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2014 | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balan... | A femoral component containing pegs was found in a box for the pegless version. | Class II | Ortho Development Corporation |
| Apr 1, 2014 | TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous... | The shell was missing the locking ring. | Class II | Zimmer, Inc. |
| Apr 1, 2014 | Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculatur... | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delive... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Apr 1, 2014 | Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray ... | Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerato... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 31, 2014 | The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic ... | GE Healthcare has identified a potential safety issue related to the screws that attach the works... | Class II | GE OEC Medical Systems, Inc |
| Mar 31, 2014 | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automati... | A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the abili... | Class II | Philips Medical Systems, Inc. |
| Mar 31, 2014 | Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized u... | Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more fr... | Class II | NEO METRICS, INC. |
| Mar 31, 2014 | EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 | The voluntary recall is due to the needle set not meeting its specifications. | Class II | Vidacare Corporation |
| Mar 28, 2014 | Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE... | Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ C... | Class II | Terumo Cardiovascular Systems Corp |
| Mar 28, 2014 | GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 223... | Urgent Device Correction notifications are being sent to USA distributors with follow-up to surge... | Class II | DePuy Orthopaedics, Inc. |
| Mar 28, 2014 | Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usa... | Problem with low adhesion of the tubing to luer connection which may lead to a separation of the... | Class II | RGI Medical Manufacturing, Inc. |
| Mar 28, 2014 | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number... | New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfi... | Class II | Integra LifeSciences Corporation |
| Mar 27, 2014 | Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brillian... | Block assembly-lock stop subframe of service latch was not manufactured to engineering specificat... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 27, 2014 | INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version... | An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrat... | Class II | INO Therapeutics (dba Ikaria) |
| Mar 27, 2014 | GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specializ... | GE Healthcare has recently become aware of a potential safety issue where the probe power surveil... | Class II | GE Healthcare, LLC |
| Mar 27, 2014 | Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those w... | Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold ... | Class II | Central Purchasing LLC DBA Harbor Freight Tools |
| Mar 27, 2014 | Proteus 235 Proton Therapy System for cancer treatment. | While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low... | Class II | Ion Beam Applications S.A. |
| Mar 26, 2014 | VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15... | Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Prote... | Class II | Ortho-Clinical Diagnostics |
| Mar 26, 2014 | The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and... | Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was m... | Class II | Acumed LLC |
| Mar 26, 2014 | VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- ... | Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Prote... | Class II | Ortho-Clinical Diagnostics |
| Mar 26, 2014 | Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an ele... | During packaging verification testing, a failure occurred due to cuts in the packaging potentiall... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2014 | The Osteo-Clage System consists of stainless steel cable/sleeves and compress... | Manufacturing of these devices with a grade of stainless steel that is not within specifications. | Class II | Acumed LLC |
| Mar 26, 2014 | ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, P... | May be labeled with incorrect result interpretation graphics on the ToxCup lid label. | Class II | Branan Medical Corporation |
| Mar 25, 2014 | Reusable latex breathing bags with multiple part numbers and sold as part of ... | Reusable latex breathing bags with various part numbers and sold as part of test lung and reusabl... | Class II | Draeger Medical, Inc. |
| Mar 25, 2014 | LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Consta... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira Inc. |
| Mar 25, 2014 | Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 4... | Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, L... | Class II | Ormco/Sybronendo |
| Mar 25, 2014 | LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira Inc. |
| Mar 25, 2014 | Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number ... | Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 0... | Class II | Ormco/Sybronendo |
| Mar 25, 2014 | LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); Fo... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira Inc. |
| Mar 25, 2014 | LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compat... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira 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.