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 |
|---|---|---|---|---|
| Dec 20, 2019 | Arrow EPIDURAL NEEDLE KIT SL-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow SPINAL ANESTHESIA SET ASA-25090-S | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT AM-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Maximal Barrier Drape ASK-00002-1A | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ S... | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT CK-02220 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT YC-02220 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Central Venous Catheterization Kit ASK-04200-UPM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | PICC Set- PR-35052-HPHNM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray Sys... | The potential exists for system movement to be permanently blocked by an activation of the collis... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - ... | 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 16MM STERILE, Part Number 04.210.116TS - ... | 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 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 |
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.