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 |
|---|---|---|---|---|
| Feb 2, 2023 | ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table ... | If, during the procedure, X-ray has been released and a reference image has been stored, the foll... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 2, 2023 | ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET tab... | In the event of any unintended table movement, the system may not detect the incorrect direction,... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Jan 23, 2023 | NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S)... | The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... | Class I | Draeger Medical, Inc. |
| Jan 23, 2023 | NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP0... | The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... | Class I | Draeger Medical, Inc. |
| Dec 22, 2022 | Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow l... | In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation l... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within t... | A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance o... | Class II | Olympus Corporation of the Americas |
| Dec 21, 2022 | Luminos dRF with software VD10- A diagnostic imaging system for radiographic... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos Agile with software VC10 - A diagnostic imaging system for radiograp... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system f... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 16, 2022 | System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Ar... | In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach f... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 16, 2022 | ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor | Mechanical connection between the tabletop and table base may be lost. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 13, 2022 | SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) | A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-... | Class II | Olympus Corporation of the Americas |
| Dec 9, 2022 | AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF | There is potential for the footrest to detach from the patient table during use. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | AXIOM Luminos Agile | There is potential for the footrest to detach from the patient table during use. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max | There is potential for the footrest to detach from the patient table during use. Device intend... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 7, 2022 | Philips Garbin Ventilator, Model Number 1058180B | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1... | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U10... | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 5, 2022 | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFE... | A software update (v1.1.5) has been developed to address the issue of Critical Failure which can ... | Class I | Cardiac Assist, Inc |
| Nov 30, 2022 | Source Administration Set (SAS) used with the Medrad Intego PET Infusion Syst... | Black specks may be present on the packaged needles | Class II | Bayer Medical Care, Inc. |
| Nov 23, 2022 | LUMINOS Lotus Max (VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | Luminos dRF Max (VE10, VF10, VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | Luminos Agile Max (VE10, VF10, VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 18, 2022 | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | The firm has received complaints of the device becoming hot. The firm has updated the user manual... | Class II | DeVilbiss Healthcare LLC |
| Nov 16, 2022 | Programmable Diagnostic Computer | The firm will be performing a software update to address a software error which affects the liste... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 9, 2022 | ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3... | When selecting the site fraction group for treatment, the User may select the wrong site for trea... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 4, 2022 | HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S | An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be c... | Class II | Olympus Corporation of the Americas |
| Sep 28, 2022 | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the so... | Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, i... | Class II | X-NAV Technologies, LLC |
| Sep 27, 2022 | SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Us... | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 20, 2022 | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens has become aware of three potential software issues with ARTIS pheno systems with softwar... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 19, 2022 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administratio... | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patie... | Class II | DeVilbiss Healthcare LLC |
| Sep 16, 2022 | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical a... | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of acces... | Class II | Olympus Corporation of the Americas |
| Sep 15, 2022 | Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per ca... | The extension set has a high probability of failure which could lead to possible leakage or detac... | Class II | B. Braun Medical, Inc. |
| Sep 15, 2022 | ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 uni... | The extension set has a high probability of failure which could lead to possible leakage or deta... | Class II | B. Braun Medical, Inc. |
| Sep 15, 2022 | CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per c... | The extension set has a high probability of potential failure which could lead to possible leakag... | Class II | B. Braun Medical, Inc. |
| Sep 6, 2022 | Philips Respironics DreamWear Full Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Therapy Mask 3100 NC/SP | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Philips Respironics Amara View Minimal Contact Full-Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | DreamWisp Nasal Mask with Over the Nose Cushion | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Wisp and Wisp Youth Nasal Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 1, 2022 | Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive ant... | Potential for leakage at the catheter hub. | Class II | B Braun Medical Inc |
| Aug 30, 2022 | Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a pack... | Class II | Synthes (USA) Products LLC |
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.