Browse Device Recalls

2,984 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,984 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 2,984 FDA device recalls in PA.

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DateProductReasonClassFirm
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
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

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.