Browse Device Recalls

709 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 709 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 709 FDA device recalls in NC.

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DateProductReasonClassFirm
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 22, 2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G5657... There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... Class II Wilson-Cook Medical Inc.
May 22, 2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G210... There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... Class II Wilson-Cook Medical Inc.
May 19, 2023 ARROW Endurance Extended Dwell Peripheral Catheter System Potential for catheter separation or leakage Class I ARROW INTERNATIONAL Inc.
Apr 28, 2023 Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for us... Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for... Class II TELEFLEX LLC
Apr 12, 2023 Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 400... The product contains an expired diluent vial. If the impacted product is used, the sterility of t... Class II TELEFLEX LLC
Mar 31, 2023 greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, no... Some of the tubes may be incorrectly labeled. Class II Greiner Bio-One North America, Inc.
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasa... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 8, 2022 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended ... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotrache... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Nov 15, 2022 ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) d... Class II ConvaTec, Inc
Nov 4, 2022 Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter i... XXX Class II Medical Action Industries, Inc. 306
Oct 27, 2022 Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheter... There is the potential for inadequate connection between the top and bottom housings of the Micro... Class I ARROW INTERNATIONAL Inc.
Oct 27, 2022 Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a)... There is the potential for inadequate connection between the top and bottom housings of the Micro... Class I ARROW INTERNATIONAL Inc.
Oct 25, 2022 GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, I... The product was recalled because stability evaluation of the lots indicated a decrease in reactiv... Class II Greer Laboratories, Inc.
Oct 25, 2022 GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSE... The product was recalled because stability evaluation of the lots indicated a decrease in reactiv... Class II Greer Laboratories, Inc.
Oct 24, 2022 TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; a... The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvas... Class II Trackx Technology Inc
Oct 17, 2022 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IP... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF I... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IP... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN00... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I ARROW INTERNATIONAL Inc.
Oct 17, 2022 Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF I... There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... Class I 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.