Browse Device Recalls
726 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 726 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 726 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 11, 2014 | Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Prod... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 4, 2014 | Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800... | Sterility of the product cannot be guaranteed. | Class II | Teleflex Medical |
| Feb 28, 2014 | Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube se... | The product may fail to achieve seal of right lung due to the cuff inflating to one side | Class II | 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, 6.0, 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, 8.0, 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, 9.0, 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 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 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, 7.0, 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, 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 |
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.