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
Oct 17, 2016 Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Sk... Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table heig... Class II Siemens Medical Solutions USA, Inc
Oct 3, 2016 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class II Synthes (USA) Products LLC
Oct 3, 2016 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class II Synthes (USA) Products LLC
Oct 3, 2016 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class II Synthes (USA) Products LLC
Oct 3, 2016 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class II Synthes (USA) Products LLC
Oct 3, 2016 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class II Synthes (USA) Products LLC
Oct 3, 2016 3.0 mm Reaming Rod/950 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class II Synthes (USA) Products LLC
Oct 3, 2016 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class II Synthes (USA) Products LLC
Oct 3, 2016 Extraction Hook - Sterile for TI Cannulated Nails The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class II Synthes (USA) Products LLC
Sep 30, 2016 PET Infusion Pump The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet ... Class II Bayer Healthcare
Sep 6, 2016 Syngo.plaza VB10A, Picture Archiving and Communication System Software upgrade to eliminate several issues Class II Siemens Medical Solutions USA, Inc
Sep 6, 2016 Syngo.plaza, Picture Archiving and Communication System Software upgrade to eliminate several issues Class II Siemens Medical Solutions USA, Inc
Sep 2, 2016 HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD th... Labeling inconsistency Class II Arrow International Inc
Aug 24, 2016 Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24... Out of Specification Microbiological test results Class II Azer Scientific, Inc.
Aug 24, 2016 Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 ... Out of Specification Microbiological test results Class II Azer Scientific, Inc.
Aug 8, 2016 Arterial Line Catheterization Kit with Sharps Safety Features Permits access... Shipping carton labeling error. Class II Arrow International Inc
Aug 8, 2016 Radial Artery Catheterization Kit with Sharps Safety Features Permits access... Shipping carton labeling error. Class II Arrow International Inc
Aug 5, 2016 Syngo.via picture archiving and communication system Syngo via is a softwa... Software error. Incorrect values for the volume calculation from a freehand VOI at the customer ... Class II Siemens Medical Solutions USA, Inc
Aug 5, 2016 Syngo.x picture archiving and communication system Syngo.x is a software s... Software error. Incorrect values for the volume calculation from a freehand VOI at the customer ... Class II Siemens Medical Solutions USA, Inc
Aug 2, 2016 Syngo Plaza picture archiving and communication system (PAC) (PACS) intended ... Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows ... Class II Siemens Medical Solutions USA, Inc
Aug 2, 2016 Certegra Workstation used in conjunction with Medrad Stellant CT Injection Sy... CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exh... Class II Bayer Healthcare
Aug 2, 2016 Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, proc... Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows ... Class II Siemens Medical Solutions USA, Inc
Aug 1, 2016 YSIO Max Product Usage: The Ysio Max is a radiographic system used in ho... Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... Class II Siemens Medical Solutions USA, Inc
Aug 1, 2016 Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radi... Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... Class II Siemens Medical Solutions USA, Inc
Aug 1, 2016 Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture There is a potential for the needle to detach from the suture thread during surgery. If the need... Class II Aesculap Implant Systems LLC
Aug 1, 2016 Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion sy... Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... Class II Siemens Medical Solutions USA, Inc
Jul 29, 2016 Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start... Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) ... Class II B. Braun Medical, Inc.
Jul 26, 2016 ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS brande... Software patch installation to address several safety issues. Class II Siemens Medical Solutions USA, Inc
Jul 26, 2016 PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerat... Software patch installation to address several safety issues. Class II Siemens Medical Solutions USA, Inc
Jul 26, 2016 Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a sof... Software patch installation to address several safety issues. Class II Siemens Medical Solutions USA, Inc
Jul 20, 2016 OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for th... Failed stability testing at 8 months. This lot produced intermittent false negative results for ... Class I OraSure Technologies, Inc.
Jul 13, 2016 SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 co... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, c... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Ar... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, co... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / ze... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic ... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 11, 2016 Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DEx... B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tr... Class II B. Braun Medical, Inc.
Jul 7, 2016 Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Mo... Due to an error in the 19 Live Display, image reproduction may fail in the examination room and ... Class II Siemens Medical Solutions USA, Inc
Jul 7, 2016 Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is ... Arrow is recalling due to incorrect labeling of products. Class II Arrow International Inc
Jun 28, 2016 Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm... It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Sta... Class II Synthes (USA) Products LLC
Jun 23, 2016 Syngo.via, picture archiving and communications system software controlled. ... Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018... Class II Siemens Medical Solutions USA, Inc
Jun 23, 2016 OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when usi... Class II Olympus Corporation of the Americas
Jun 22, 2016 Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #... Risk associated with operating the device in skin temperature mode with temperature sensors attac... Class II Draeger Medical, Inc.
Jun 9, 2016 Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDR... Bayer Healthcare is initiating this recall due to complaints that were received from customer sit... Class II Bayer Healthcare
Jun 7, 2016 Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw ... DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (P... Class II Synthes (USA) Products LLC
Jun 6, 2016 SYNGO Breast Care, visualization and image enhancement tools to aid radiolog... Software issues. Siemens is voluntarily initiating a recall after they became aware of the follow... Class II Siemens Medical Solutions USA, Inc
Jun 2, 2016 Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K ... Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and... Class II Arrow International Inc
Jun 2, 2016 Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K ... Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and... Class II Arrow International Inc
Jun 2, 2016 ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS... Arrow is recalling these products due to the possibility that although the kit is labeled as cont... Class II Arrow International 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.