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 |
|---|---|---|---|---|
| Sep 8, 2014 | Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and d... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Gardner-Wells traction tongs are skull tongs for traction used to immobilize ... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | McKenzie enlarging burrs are bone cutting and drilling instruments that are u... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | A zipser clamp is an instrument used to compress reduce blood flow to the pen... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | D'errico perforator drills are bone cutting and drilling instruments that are... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 5, 2014 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... | The software issue described was corrected in the modification to the MXTTOUT controller paramete... | Class II | Zimmer Biomet, Inc. |
| Sep 5, 2014 | GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Pr... | GE Healthcare has become aware of a potential safety issue involving missing screws used for moun... | Class II | GE Healthcare, LLC |
| Sep 5, 2014 | Philips Expression MR200 MRI Patient Monitoring System | Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. | Class II | Invivo Corporation |
| Sep 4, 2014 | Vantage Panoramic X-Ray System used to perform dental and orthodontic radiolo... | Failure of the primary collimator may result in unintentional movement of the device. The uninten... | Class II | Midmark Corp dba Progeny Inc |
| Sep 4, 2014 | Innova 4100IQ Indicated for use in generating fluoroscopic images of human... | Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... | Class II | GE Healthcare, LLC |
| Sep 4, 2014 | Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile.... | Misbranding: Although the product labeling identifies the catheters as "soft rubber," t... | Class II | Teleflex Medical |
| Sep 4, 2014 | Discovery IGS 740 Indicated for use for patients from newborn to geriatric... | Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... | Class II | GE Healthcare, LLC |
| Sep 4, 2014 | Innova IGS 540 Indicated for use for patients from newborn to geriatric in... | Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... | Class II | GE Healthcare, LLC |
| Sep 3, 2014 | SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled... | One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps acc... | Class II | Baxter Healthcare Corp. |
| Sep 3, 2014 | Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB... | Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the... | Class II | Teleflex Medical |
| Sep 3, 2014 | RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as... | Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in... | Class II | DePuy Orthopaedics, Inc. |
| Sep 3, 2014 | Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 102... | Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the... | Class II | Teleflex Medical |
| Sep 2, 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for mu... | Aerogen has received a small number of complaints in relation to the main power adapter manufactu... | Class II | Aerogen Ltd. |
| Sep 2, 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for mu... | Aerogen has received a small number of complaints in relation to the main power adapter manufactu... | Class II | Aerogen Ltd. |
| Sep 2, 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for mu... | Aerogen has received a small number of complaints in relation to the main power adapter manufactu... | Class II | Aerogen Ltd. |
| Sep 2, 2014 | Siemens Ysio Max system The Ysio Max is a radiographic system used in hospit... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm par... | DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Pl... | Class II | Synthes, Inc. |
| Sep 2, 2014 | Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detecto... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | Siemens Luminos Agile Max system The Luminos Agile is intended to be used a... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | The Aeroneb Professional Nebulizer System is a portable medical device for mu... | Aerogen has received a small number of complaints in relation to the main power adapter manufactu... | Class II | Aerogen Ltd. |
| Sep 2, 2014 | Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 1, 2014 | Fluid Management System P4000; for irrigation and fluid warming in laparosco... | To correct software bugs that could affect the ability to accurately measure fluid deficit. | Class II | Thermedx LLC |
| Sep 1, 2014 | Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Inte... | The firm received complaints regarding multiple mattresses were showing failures resulting in pre... | Class II | Arjo Hospital Equipment AB |
| Aug 29, 2014 | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS4... | Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has d... | Class II | Dako North America Inc. |
| Aug 28, 2014 | Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnos... | Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calib... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 28, 2014 | Bionector Needleless connector. Bionector is a multi-purpose catheter accesso... | Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needlel... | Class II | Vygon Corporation |
| Aug 28, 2014 | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components ... | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studie... | Class II | Merge Healthcare, Inc. |
| Aug 28, 2014 | TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Po... | Motion Concepts identified that there is a possibility of knee support failure occurring through ... | Class II | Motion Concepts |
| Aug 27, 2014 | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic mon... | Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglo... | Class II | Mckesson Information Solutions LLC |
| Aug 27, 2014 | The Ysio Systems with software version VC10 The Ysio enables radiographic ... | Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 27, 2014 | Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx O... | JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products becaus... | Class II | Justright Surgical, LLC |
| Aug 27, 2014 | GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS... | Due to an anomaly in the packaging process, it is possible that a defective seal could be present... | Class II | Gyrus Medical, Inc |
| Aug 27, 2014 | Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International ... | The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. | Class II | DePuy Orthopaedics, Inc. |
| Aug 27, 2014 | Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx On... | JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products becaus... | Class II | Justright Surgical, LLC |
| Aug 26, 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part num... | Sterility of device is not assured | Class II | Bio-Detek, Inc. |
| Aug 26, 2014 | Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Ar... | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. ... | Class II | Spacelabs Healthcare Inc |
| Aug 26, 2014 | The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm... | The expiration date of the bar code on the envelope label did not match the expiration date next ... | Class II | MAST Biosurgery USA, Inc |
| Aug 26, 2014 | Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) ... | Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at... | Class II | Bard Peripheral Vascular Inc |
| Aug 26, 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012... | Sterility of device is not assured | Class II | Bio-Detek, Inc. |
| Aug 26, 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadw... | Sterility of device is not assured | Class II | Bio-Detek, Inc. |
| Aug 25, 2014 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LU... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, 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.