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 |
|---|---|---|---|---|
| May 2, 2016 | DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgica... | Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test... | Class II | Synthes (USA) Products LLC |
| Apr 26, 2016 | WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous deliver... | Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle gu... | Class II | B. Braun Medical, Inc. |
| Apr 21, 2016 | Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bot... | Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling proc... | Class II | Draeger Medical, Inc. |
| Apr 18, 2016 | 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Prod... | The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... | Class II | Synthes (USA) Products LLC |
| Apr 18, 2016 | 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product U... | The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... | Class II | Synthes (USA) Products LLC |
| Apr 14, 2016 | Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: ... | BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... | Class II | B. Braun Medical, Inc. |
| Apr 14, 2016 | Syngo Dynamics; Kinetdx Picture Archiving and Communications System | Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syng... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 14, 2016 | Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve ... | BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... | Class II | B. Braun Medical, Inc. |
| Apr 13, 2016 | MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, M... | The docking station top cover of the removable patient table may contain a magnetic metal plate. ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 4, 2016 | 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID #... | This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped afte... | Class II | Synthes (USA) Products LLC |
| Apr 1, 2016 | SOMATOM Force, Computed Tomography x-ray system intended to generate and ... | The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly l... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Seria... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The D... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product ... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Apr 1, 2016 | Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710... | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | Class I | B Braun Medical Inc |
| Mar 22, 2016 | SOMATOM Definition AS, a family of CT systems intended to produce cross-secti... | Siemens became aware that the front cover on some Siemens CT system was not properly welded. It ... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 15, 2016 | EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus v... | New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised man... | Class II | Olympus Corporation of the Americas |
| Mar 11, 2016 | Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiog... | After importing segmentation results of the left atrium created on the Artis One system, the poss... | Class II | Siemens Medical Solutions USA, Inc |
| 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 |
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.