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 |
|---|---|---|---|---|
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 12, 2019 | Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane ove... | The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instea... | Class II | Arrow International Inc |
| Dec 6, 2019 | Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH | Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Ca... | Class II | Arrow International Inc |
| Nov 25, 2019 | Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X... | During a routine inspection of a system, a crack on the C-arm holder was discovered. In the even... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 20, 2019 | Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 | Potential for leakage at the joint between the blood filters and tubing | Class II | B. Braun Medical, Inc. |
| Nov 20, 2019 | Safeline Y-Type Blood Set, Catalog Number NF5140 | Potential for leakage at the joint between the blood filters and tubing | Class II | B. Braun Medical, Inc. |
| Nov 20, 2019 | Safeline Y-Type Blood Set, Catalog Number V2500 | Potential for leakage at the joint between the blood filters and tubing | Class II | B. Braun Medical, Inc. |
| Nov 20, 2019 | Y-Type Blood Set, Catalog Number 490314 | Potential for leakage at the joint between the blood filters and tubing | Class II | B. Braun Medical, Inc. |
| Nov 20, 2019 | Y-Type Blood Set, Catalog Number 490530 | Potential for leakage at the joint between the blood filters and tubing | Class II | B. Braun Medical, Inc. |
| Nov 20, 2019 | Y-Type Blood Set, Catalog Number 490293 | Potential for leakage at the joint between the blood filters and tubing | Class II | B. Braun Medical, Inc. |
| Nov 20, 2019 | Y-Type Blood Set, Catalog Number 490425 | Potential for leakage at the joint between the blood filters and tubing | Class II | B. Braun Medical, Inc. |
| Nov 19, 2019 | TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product ... | The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. | Class II | Cardiac Assist, Inc |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy E... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Tril... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is inte... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is int... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is i... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is inten... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is i... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 15, 2019 | Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 | Potential leak in the balloon extension line. If a leak was present and went undetected during pr... | Class II | Arrow International Inc |
| Nov 15, 2019 | Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J | Potential leak in the balloon extension line. If a leak was present and went undetected during pr... | Class II | Arrow International Inc |
| Nov 14, 2019 | Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 1009... | In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collis... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 12, 2019 | ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo... | Nonfunctional key due to the potential for damage to the key pins cause by force of use during as... | Class II | Aesculap Implant Systems LLC |
| Oct 7, 2019 | Software versions syngo CT VB20 running on the following Siemens SOMATOM CT ... | Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanne... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 1, 2019 | Aesculap Sterile disposable fleece drape, Product code: GA414, individually p... | Packaging seal integrity not validated resulting in a lack of sterility assurance. | Class II | Aesculap Implant Systems LLC |
| Sep 25, 2019 | AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual ... | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. | Class II | Aesculap Implant Systems LLC |
| Sep 24, 2019 | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 19, 2019 | Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgi... | The sterile barrier of some devices may have been affected | Class II | Xodus Medical Inc |
| Sep 19, 2019 | Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory | The sterile barrier of some devices may have been affected | Class II | Xodus Medical Inc |
| Sep 19, 2019 | Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical a... | The sterile barrier of some devices may have been affected | Class II | Xodus Medical Inc |
| Sep 16, 2019 | Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 fo... | The subject product measures 4.0mm in diameter instead of 3.5mm. | Class II | Synthes (USA) Products LLC |
| Sep 12, 2019 | Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Pr... | Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-ha... | Class II | Olympus Corporation of the Americas |
| Sep 5, 2019 | MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with ... | Modified outside of approved manufacturing process | Class II | Synthes (USA) Products LLC |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrume... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrum... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| Aug 6, 2019 | Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product ... | Products may contain the incorrect banner card within the kit | Class II | Arrow International Inc |
| Aug 6, 2019 | 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Cat... | Products may contain the incorrect banner card within the kit | Class II | Arrow International Inc |
| Jul 31, 2019 | SOMATOM go.All; Models #11061630 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography ... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.All; Models #11061638 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This compute... | The injector holder could potentially fall off together with the injector and the storage box. | 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.