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 |
|---|---|---|---|---|
| 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 |
| 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 |
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.