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 |
|---|---|---|---|---|
| May 11, 2021 | novaplus, General Purpose Kit, Cat. No. 56603 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Blood Culture MAI Kit Part Number: 80076 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Injection REVIEW MAI Kit Part Number: 74736 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Midline Insertion DA. MAI Kit Part Number: 77981B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Blood Culture. MAI Kit Part Number: 80315D | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Mar 29, 2021 | VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blu... | VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw vo... | Class II | Greiner Bio-One North America, Inc. |
| Mar 1, 2021 | Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "... | The kit does not have an emergency use authorization (EUA). | Class II | Cellex |
| Feb 18, 2021 | RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visual... | Teleflex is voluntarily recalling the products referenced above due to customers reporting that t... | Class II | TELEFLEX MEDICAL INC |
| Feb 12, 2021 | PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter i... | Teleflex is recalling this product due to a lack of assurance of sterility. | Class II | TELEFLEX MEDICAL INC |
| Dec 23, 2020 | Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood co... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenie... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood con... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection ... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood conveni... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Aug 28, 2020 | VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P -... | Blood collection tubes experienced an issue with separation and clotting | Class II | Greiner Bio-One North America, Inc. |
| Aug 7, 2020 | Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter ... | Potential sterility issue | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Produc... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Produc... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Produc... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product ... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Produ... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Produc... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Produc... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jun 30, 2020 | Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage:... | Potential for sterile packaging to be compromised¿ | Class II | TELEFLEX MEDICAL INC |
| Jun 30, 2020 | Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product ... | Potential for sterile packaging to be compromised¿ | Class II | TELEFLEX MEDICAL INC |
| May 29, 2020 | RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 10... | Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicat... | Class II | TELEFLEX MEDICAL INC |
| Apr 20, 2020 | Oscar 2, Model 250 System | The device display, when activated, can show an incorrect decimal point when the blood pressure r... | Class II | Suntech Medical, Inc. |
| Mar 12, 2020 | VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot n... | Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the... | Class II | Greiner Bio-One North America, Inc. |
| Mar 6, 2020 | AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready... | The UDI on the device label indicates incorrect manufacturer. | Class III | Linet Americas |
| Feb 14, 2020 | NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Pa... | There is a software issue which may result in failure to monitor or control patient's bed exit me... | Class II | Hill-Rom Inc. |
| Feb 5, 2020 | VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system con... | The top seal of some of the pouches was compromised which can allow moisture to enter that can im... | Class II | bioMerieux, Inc. |
| Feb 4, 2020 | HEMO-10 Hemospray Endoscopic Hemostat | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when... | Class II | Wilson-Cook Medical Inc. |
| Feb 4, 2020 | HEMO-7 Hemospray Endoscopic Hemostat | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when... | Class II | Wilson-Cook Medical Inc. |
| Jan 24, 2020 | PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units... | The recall has been initiated due to potential for overheating or a fire hazard associated with ... | Class II | bioMerieux, Inc. |
| Jan 13, 2020 | Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm,... | There is a potential for the device packaging to become compromised; thus, the sterility of the d... | Class II | TELEFLEX MEDICAL INC |
| Jan 13, 2020 | Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 | There is a potential for the device packaging to become compromised; thus, the sterility of the d... | Class II | TELEFLEX MEDICAL INC |
| Jan 9, 2020 | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System | The products are being recalled due to reports of breakage broke at the point of a welded joint e... | Class II | TELEFLEX MEDICAL INC |
| Jan 9, 2020 | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System | The products are being recalled due to reports of breakage broke at the point of a welded joint e... | Class II | TELEFLEX MEDICAL INC |
| Dec 13, 2019 | HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperatu... | There is the potential for water to flood the column and enter the circuit under circumstances wh... | Class I | TELEFLEX MEDICAL INC |
| Dec 13, 2019 | HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, RE... | There is the potential for water to flood the column and enter the circuit under circumstances wh... | Class I | TELEFLEX MEDICAL INC |
| Dec 13, 2019 | HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier... | There is the potential for water to flood the column and enter the circuit under circumstances wh... | Class I | TELEFLEX MEDICAL INC |
| Dec 13, 2019 | HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit | There is the potential for water to flood the column and enter the circuit under circumstances wh... | Class I | TELEFLEX MEDICAL INC |
| Dec 11, 2019 | Model 250D Ambulatory Blood Pressure Monitor labeled under the following bran... | The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalle... | Class II | Suntech Medical, Inc. |
| Dec 10, 2019 | VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit | Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which ... | Class II | bioMerieux, Inc. |
| Dec 2, 2019 | Medical convenience trays and kits, labeled as: Medical Action Industries,... | The kits contain a bottle of saline solution which may exceed the USP specified pH requirements o... | Class II | Medical Action Industries, Inc. 306 |
| Nov 25, 2019 | VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usag... | The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. ... | Class II | Greiner Bio-One North America, Inc. |
| Oct 30, 2019 | HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usa... | The tracheal and brochial swivel connectors are incorrectly labeled. | Class II | Teleflex Medical |
| Oct 11, 2019 | Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex M... | Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical... | Class II | TELEFLEX MEDICAL 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.