Browse Device Recalls

2,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,969 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 2,969 FDA device recalls in PA.

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DateProductReasonClassFirm
Mar 11, 2016 Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manu... One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may ... Class II Integra York PA, Inc
Mar 2, 2016 Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images ... Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... Class II Siemens Medical Solutions USA, Inc
Mar 2, 2016 Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of ... Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... Class II Siemens Medical Solutions USA, Inc
Mar 2, 2016 GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems.... Radiation emissions which exceeded the limit in the performance standard were detected during mai... Class II GE Inspection Technologies, LP
Mar 2, 2016 Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash a... Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... Class II Siemens Medical Solutions USA, Inc
Mar 2, 2016 Siemens SOMATOM Definition: Intended to produce cross-sectional images of the... Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients wit... Class II Siemens Medical Solutions USA, Inc
Feb 26, 2016 system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, ... In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cab... Class II Siemens Medical Solutions USA, Inc
Feb 24, 2016 syngo X Workplace is a medical workstation for real-time viewing, image manip... After importing, the segmentation results appear mirrored at the CARTO system and can't be used f... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2016 Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, ... Out of specification at the thread. The thread height of these screws is under-sized. The cross s... Class II Synthes (USA) Products LLC
Feb 23, 2016 X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical N... The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with regist... Class II X-NAV Technologies, LLC
Feb 23, 2016 Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, ... Out of specification at the thread. The thread height of these screws is under-sized. The cross s... Class II Synthes (USA) Products LLC
Feb 19, 2016 AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic i... Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. T... Class II Siemens Medical Solutions USA, Inc
Feb 19, 2016 Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnost... Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. T... Class II Siemens Medical Solutions USA, Inc
Feb 19, 2016 Cios Alpha, mobile X-ray system Software issues on Cios Alpha mobile C-Arm system Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM A... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion ca... The label on the outer packaging does not match the product inside and intended use of the device. Class II Synthes (USA) Products LLC
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM A... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2016 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... Class II Siemens Medical Solutions USA, Inc
Feb 17, 2016 Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arr... Notification of component molding abnormality by supplier used to package certain Arrow Select Ki... Class II Arrow International Inc
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

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.