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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

768 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 768 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 768 FDA device recalls in NC.

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DateProductReasonClassFirm
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
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

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.