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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.