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Browse Device Recalls

712 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 712 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 712 FDA device recalls in NC.

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DateProductReasonClassFirm
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... The tracheal tube can kink during patient use. Class I Teleflex Medical
Jan 6, 2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx... The tracheal tube can kink during patient use. Class I Teleflex Medical
Dec 19, 2013 Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with S... Sterility cannot be guaranteed. Class II Teleflex Medical
Dec 19, 2013 Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with S... Sterility cannot be guaranteed. Class II Teleflex Medical
Oct 17, 2013 Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief,... Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol. Class II GlaxoSmithKline, LLC.
Oct 15, 2013 Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upp... Labeling inconsistency Class II Teleflex Medical
Sep 6, 2013 chromID Salmonella Agar, Reference No. 43621. A selective isolation and di... Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colo... Class II bioMerieux, Inc.
Aug 26, 2013 Crocodile (size 3) are two-armed, wheeled walking aids, used by children with... The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to... Class II Snug Seat Inc
Aug 8, 2013 Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, S... The manufacturing and expiration dates are not printed on the blister pack label. Class II Teleflex Medical
Jul 12, 2013 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical S... No endotoxin (LAL) testing to proper level. Class II Custom Medical Specialties, Inc.
Apr 5, 2013 PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitativ... Review of validation information and customer complaints which indicated preliminary screen posit... Class II Medtox Diagnostics Inc
Mar 28, 2013 Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile uri... Sterile packaging may be compromised. Class II Teleflex Medical
Mar 15, 2013 McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care syst... There was an occurrence where the patient case data did not match the patient data when the case ... Class I MCKESSON TECHNOLOGIES INC.
Feb 19, 2013 Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of ... WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock... Class II Tecan US, Inc.
Feb 7, 2013 Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medi... Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. Class II Myco Medical Supplies Inc
Feb 1, 2013 VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Coll... The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) duri... Class II Greiner Bio-One North America, Inc.
Dec 25, 2012 BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is in... BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. Class II bioMerieux, Inc.
Sep 25, 2012 Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Telefl... Product is being recalled due to the possibility that the tray may contain pinholes, compromising... Class II Teleflex Medical
Jul 20, 2012 TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medica... Product is missing the label on the internal packaging. Class III Teleflex Medical
Jul 11, 2012 Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporatio... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Sta... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporatio... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufa... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ven... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation,... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable ... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The ... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufact... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufact... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufacture... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 2, 2012 SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Ins... Some clip applier units may be inadequate to achieve clip closure. Class II Transenterix, Inc
Jul 2, 2012 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North... Part of the lot received a lower concentration of citrate solution which may cause falsely lower ... Class II Greiner Bio-One North America, Inc.
Jun 12, 2012 Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usag... Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, th... Class II Teleflex Medical
Apr 2, 2012 Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. ... : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green ... Class II Greiner Bio-One North America, Inc.
Mar 22, 2012 Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit,... The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain Syringing Pipettes 240 (Catalog #490517) The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Dec 8, 2011 PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... Class II Tripath Imaging, Inc.
Dec 8, 2011 PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a li... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... Class II Tripath Imaging, Inc.
Dec 8, 2011 PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin ... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... Class II Tripath Imaging, Inc.
Dec 8, 2011 PrepStain Slide Processor. The PrepStain System is a liquid-based thin lay... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... Class II Tripath Imaging, Inc.
Sep 30, 2011 CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution P... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Pro... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiolo... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage:... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, 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.