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
Jul 30, 2019	Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 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 EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 ...	Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec...	Class I	Teleflex Medical
Jul 24, 2019	Hemospray Endoscopic Hemostat	Potential for Hemospray device to be unable to spray powder due to misassembly of devices.	Class II	Wilson-Cook Medical Inc.
Jul 1, 2019	Rusch EasyCath Kit	Potential for product not to be sterile.	Class II	Teleflex Medical
Jun 14, 2019	Acuject Variable Injection Needle	Potential for occluded injection needles.	Class II	Wilson-Cook Medical Inc.
Jun 14, 2019	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with v...	Device vented gas below the stated pressure.	Class I	TELEFLEX-MORRISVILLE
Jun 3, 2019	SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure ...	Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 ...	Class II	Suntech Medical, Inc.
May 24, 2019	Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b)...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm,...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tub...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Trachea...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Pro...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 10, 2019	Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated L...	Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonata...	Class I	Teleflex Medical
May 3, 2019	Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and hig...	Insulin dosing calculations were erroneously high.	Class II	Monarch Medical Technologies
Apr 29, 2019	DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraor...	The sensor's look up calibration files were incorrectly programmed during manufacturing, which ca...	Class II	KaVo Dental Technologies LLC
Apr 12, 2019	Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks,...	Gas springs not always replaced within the interval specified.	Class II	Tecan US, Inc.
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. m...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Mar 15, 2019	Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of ...	Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherich...	Class II	bioMerieux, Inc.
Mar 1, 2019	Laparotomy Sponge with the following product description and model numbers: ...	Potential lack of sterility assurance	Class II	Medical Action Industries Inc
Feb 27, 2019	Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF ...	The device label incorrectly states that the device is sterile. This product is an externally app...	Class III	Teleflex Medical
Feb 27, 2019	Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF...	The device label incorrectly states that the device is sterile. This product is an externally app...	Class III	Teleflex Medical
Jan 16, 2019	CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321	Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal...	Class III	Carolina Liquid Chemistries
Jan 16, 2019	CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321		Class III	Carolina Liquid Chemistries
Jan 14, 2019	RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device	The device labels are not UDI compliant. The missing UDI compliance information on the labelling ...	Class III	Teleflex Medical
Jan 14, 2019	RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device	The device labels are not UDI compliant. The missing UDI compliance information on the labelling ...	Class III	Teleflex Medical
Jan 11, 2019	Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID...	This notice has been initiated due to potential for compromised test card Top Seal Integrity whic...	Class II	Organon Teknika Inc
Jan 9, 2019	Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usag...	An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.	Class II	ConvaTec, Inc
Jan 9, 2019	FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: ...	An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.	Class II	ConvaTec, Inc
Jan 9, 2019	Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled ...	An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.	Class II	ConvaTec, Inc
Jan 9, 2019	Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab...	An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.	Class II	ConvaTec, Inc
Jan 7, 2019	Pilling COOLEY SUMP-SUCTION TUBE, REF 351547	The internal tip is missing from the device, causing the device to not function as intended.	Class II	Teleflex Medical
Jan 4, 2019	Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical...	Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.	Class II	Wilson-Cook Medical Inc.
Dec 31, 2018	cone-beam CT system	ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1	Class II	KaVo Dental Technologies LLC
Dec 18, 2018	COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4S...	The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) ...	Class II	Wilson-Cook Medical Inc.
Dec 18, 2018	COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with ...	The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) ...	Class II	Wilson-Cook Medical Inc.
Dec 13, 2018	VITEK 2 AST-N351 Test Kit	False Positive ESBL Phenotype	Class II	bioMerieux, Inc.
Nov 27, 2018	Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed wi...	Potential compromise of product sterility due to breach of sterile barrier.	Class II	Medical Action Industries Inc
Nov 13, 2018	VITEK¿ 2 Systems Software Version 9.01 Update Kit.	The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification...	Class II	bioMerieux, Inc.
Nov 8, 2018	Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Na...	Unintentional U-Arm movement	Class II	Konica Minolta Healthcare, Americas, Inc.
Oct 22, 2018	VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these...	False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were r...	Class II	bioMerieux, Inc.
Oct 8, 2018	bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134	Some eluates become colored because of remaining hemoglobin in the eluate.	Class II	bioMerieux, Inc.
Oct 1, 2018	PremierPro Aluminum Adjustable Walker	This recall is due to a mandated order from the FDA for stock recovery and return of the imported...	Class II	SVS LLC
Aug 13, 2018	VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Entero...	Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma...	Class II	bioMerieux, 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.