Browse Device Recalls

2,939 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,939 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 2,939 FDA device recalls in PA.

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DateProductReasonClassFirm
Feb 17, 2016 Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous acce... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An a... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 17, 2016 Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
Feb 16, 2016 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guid... DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking... Class II Synthes (USA) Products LLC
Feb 16, 2016 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: Th... Siemens found a defective part in their production line which could increase risk of an electrica... Class II Siemens Medical Solutions USA, Inc
Feb 16, 2016 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Scr... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Scr... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, ... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and ... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 15, 2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... Class II Siemens Medical Solutions USA, Inc
Feb 12, 2016 Mammomat Inspiration with Tomosynthesis functionality A potential system fatal error may occur during tomosynthesis reconstruction with large breasts t... Class II Siemens Medical Solutions USA, Inc
Feb 4, 2016 Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation C... Class I Draeger Medical, Inc.
Jan 29, 2016 software for Syngo Dynamics a Picture Archiving and Communication System ... Siemens is releasing a software update that addresses an issue of mixing data from multiple patie... Class II Siemens Medical Solutions USA, Inc
Jan 28, 2016 Large Volume Paracentesis Kit is packaged in a thermaformed tray which contai... Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the ab... Class II Gi Supply
Jan 25, 2016 Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Mo... Siemens' conducting a recall due to a potential issue when using the measurement package of the V... Class II Siemens Medical Solutions USA, Inc
Jan 18, 2016 A Picture Archiving and Communication System (PACS) intended to display, proc... To inform users about the possible incorrect values for Distance Measurements when using certain ... Class II Siemens Medical Solutions USA, Inc
Jan 18, 2016 Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbi... Software Issue Class II Philips Respironics
Jan 15, 2016 OraQuick HCV Visual Reference Panel Intended to assist new operation in b... OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Ant... Class III OraSure Technologies, Inc.
Jan 12, 2016 Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07... Arrow has issued a recall for these products due to potential packaging damage. The sterility of ... Class II Arrow International Inc
Jan 8, 2016 Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: T... Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenos... Class II Olympus Corporation of the Americas
Jan 7, 2016 Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast De... Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the ... Class II Wfr/aquaplast Corp
Jan 6, 2016 Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw... DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Can... Class II Synthes (USA) Products LLC
Dec 22, 2015 Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus V... Drager became aware of situations where the error message "Poti unplugged" was generated causing ... Class I Draeger Medical, Inc.
Dec 22, 2015 Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: ... Drager became aware of situations where the error message "Poti unplugged" was generated causing ... Class I Draeger Medical, Inc.
Dec 22, 2015 Syngo Plaza Picture archiving and communication system. Software only. PACS... Siemens is releasing an updated software version to address several software issues including RGB... Class II Siemens Medical Solutions USA, Inc
Dec 21, 2015 The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CL... The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing ... Class II Therakos Inc
Dec 16, 2015 GE Inspection Technologies, LP, Cabinet X-ray system used for industrial qual... GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems ma... Class II GE Inspection Technologies, LP
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 7, 2015 MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). Possible installation error of the quench lines of superconducting magnets, used to vent helium g... Class II Siemens Medical Solutions USA, Inc
Dec 1, 2015 Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN... The firm became aware of cases in which the battery run times of the optional PS 500 power supply... Class I Draeger Medical, Inc.
Dec 1, 2015 SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexi... The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual di... Class II Synthes (USA) Products LLC
Nov 30, 2015 Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDR... The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tub... Class II Bayer Healthcare
Nov 30, 2015 Columbus Revision Knee System, EnduRo Knee System Product Usage: The Colu... Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem impla... Class II Aesculap, Inc.
Nov 18, 2015 Software version VD10E for Syngo X-Workplace; Picture archiving and communica... Potential post-processing software issue when using tabcard "4D" on X-Workplace with software ver... Class II Siemens Medical Solutions USA, Inc
Nov 17, 2015 Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retra... AAG received a customer complaint that corrosion had been found by a hospitals central sterile s... Class II Aesculap, Inc.
Nov 17, 2015 Syngo Imaging XS is a Picture Archiving and Communication System (PACS) For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in inco... Class II Siemens Medical Solutions USA, 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.