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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Date	Product	Reason	Class	Firm
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
Oct 11, 2019	Sprotte Needle, REF 32115130C w/ Intro 22 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
Oct 8, 2019	Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, P...	The safety cap attached to needles within the needle sets may become dislodged exposing the needl...	Class II	Teleflex Medical
Oct 8, 2019	Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, P...	The safety cap attached to needles within the needle sets may become dislodged exposing the needl...	Class II	Teleflex Medical
Oct 8, 2019	Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, P...	The safety cap attached to needles within the needle sets may become dislodged exposing the needl...	Class II	Teleflex Medical
Oct 4, 2019	WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic E...	Certain clip appliers have an increase in misloading and/or jamming related complaints that may b...	Class II	Teleflex Medical
Oct 4, 2019	WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543...	Certain clip appliers have an increase in misloading and/or jamming related complaints that may b...	Class II	Teleflex Medical
Oct 1, 2019	EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)	Product was distributed prior to approval or clearance from FDA.	Class II	Monarch Medical Technologies
Sep 6, 2019	Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following br...	ConvaTec has received complaints associated with use of convex two-piece skin barriers where the ...	Class II	ConvaTec, Inc
Jul 30, 2019	Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/ai...	Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec...	Class I	Teleflex Medical
Jul 30, 2019	Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c)...	Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec...	Class I	Teleflex Medical
Jul 30, 2019	Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) ...	Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec...	Class I	Teleflex Medical
Jul 30, 2019	Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-104...	Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec...	Class I	Teleflex Medical
Jul 30, 2019	Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 m...	Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec...	Class I	Teleflex Medical
Jul 30, 2019	Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF...	Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec...	Class I	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.