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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 15, 2016 | SOMATOM Definition Edge System, x-ray, tomography, computed Intended to prod... | Software update that provides software and firmware bug-fixes to improve system performance | Class II | Siemens Medical Solutions USA, Inc |
| Nov 10, 2016 | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) P... | Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due t... | Class III | OraSure Technologies, Inc. |
| Nov 7, 2016 | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses ... | Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Integ... | Class II | Bayer Healthcare |
| Nov 3, 2016 | HF Cable WA00014A, Endoscopic electrosurgical unit and accessories | Software malfunction that results in incorrect generation or display of error codes. | Class II | Olympus Corporation of the Americas |
| Nov 2, 2016 | SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM ... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 2, 2016 | SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATO... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 2, 2016 | SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMAT... | Siemens is releasing a software update that provides bug-fixes to improve system performance for ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 1, 2016 | AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems ... | The possibility exists that the semi-automatic focus switch may not work as intended when pressin... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 1, 2016 | Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis syste... | The possibility exists that the semi-automatic focus switch may not work as intended when pressin... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 1, 2016 | Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a... | The possibility exists that the semi-automatic focus switch may not work as intended when pressin... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 1, 2016 | Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm ... | Class II | Synthes (USA) Products LLC |
| Oct 31, 2016 | Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible... | Non-conforming material used. | Class II | Synthes (USA) Products LLC |
| Oct 28, 2016 | Gomco Circumcision Clamps with separate O-Ring Component: The device is packa... | Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. | Class II | Aesculap Implant Systems LLC |
| Oct 28, 2016 | Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved... | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... | Class II | Integra York PA, Inc |
| Oct 28, 2016 | Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pea... | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... | Class II | Integra York PA, Inc |
| Oct 20, 2016 | SOMATOM Force, System x-ray, tomography, computed | Siemens is providing software update version VA50A_SP3 to address the software bugs that were i... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition Flash system, x-ray, tomography, computed | Hardware issue that may expose the user to a potential risk for serious injury due to exposure to... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition AS system, x-ray, tomography, computed | Hardware issue that may expose the User to a potential risk for serious injury due to exposure to... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM ... | A problem can occur with the small light marker windows, used for the positioning laser and are i... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2016 | SOMATOM Definition Flash, Computed tomography system Product Usage: SOMAT... | A problem can occur with the small light marker windows, used for the positioning laser and are i... | Class II | Siemens Medical Solutions USA, Inc |
| 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 |
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.