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.

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DateProductReasonClassFirm
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.
Aug 13, 2018 VITEK(R) 2 AST-P655, 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.
Jul 23, 2018 Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On ... There is a software issue that can potentially impact sample identification and traceability unde... Class II Tecan US, Inc.
Jul 3, 2018 AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient ... Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the ... Class II ConvaTec, Inc
Jun 27, 2018 BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage... The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... Class II bioMerieux, Inc.
Jun 27, 2018 BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product... The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... Class II bioMerieux, Inc.
Jun 27, 2018 BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage... The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... Class II bioMerieux, Inc.
Apr 25, 2018 Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Pro... It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier ... Class II ConvaTec, Inc
Mar 1, 2018 VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is... Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS... Class II bioMerieux, Inc.
Feb 15, 2018 Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lac... Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular device... Class II Teleflex Medical
Jan 26, 2018 bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST ... Customer reports indicated an increase in the rate of non-detected MRSA in association with the V... Class I bioMerieux, Inc.
Jan 12, 2018 Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol S... Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1... Class II Tecan US, Inc.
Jan 4, 2018 BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*... Increase of events affecting performance regarding pump clogging and displacement of the color-co... Class II bioMerieux, Inc.
Jan 4, 2018 BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) ... Increase of events affecting performance regarding pump clogging and displacement of the color-co... Class II bioMerieux, Inc.
Jan 3, 2018 Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical Sy... There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and p... Class II Teleflex Medical
Jan 3, 2018 Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical S... There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and p... Class II Teleflex Medical
Dec 11, 2017 Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels p... Product sterility potentially compromised. Class II Medical Action Industries Inc
Oct 26, 2017 SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Co... A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Ski... Class II ConvaTec, Inc
Oct 18, 2017 Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 m... Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragm... Class II Teleflex Medical
Oct 5, 2017 WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF... The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. Class II Teleflex Medical
Jul 19, 2017 Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm ... For some of the recalled products, the security of the connection between the shaft and the tool ... Class II Teleflex Medical
Jul 19, 2017 Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm atta... For some of the recalled products, the security of the connection between the shaft and the tool ... Class II Teleflex Medical
Jul 19, 2017 Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5m... For some of the recalled products, the security of the connection between the shaft and the tool ... Class II Teleflex Medical
Jul 19, 2017 Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments... For some of the recalled products, the security of the connection between the shaft and the tool ... Class II Teleflex Medical
Jul 19, 2017 Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5... For some of the recalled products, the security of the connection between the shaft and the tool ... Class II Teleflex Medical
Jul 19, 2017 Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System wit... For some of the recalled products, the security of the connection between the shaft and the tool ... Class II Teleflex Medical
Jul 5, 2017 LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 M... Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... Class II Teleflex Medical
Jun 15, 2017 Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES... The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1... Class II Custom Assemblies Inc
May 15, 2017 VIDAS Testosterone, Ref 30418 Complaints were received from customers observing falsely overestimate results or external qualit... Class II bioMerieux, Inc.
May 11, 2017 Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets m... Product size listed on the labeling is incorrect. Class II Teleflex Medical
May 10, 2017 Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubin... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O... Class II ConvaTec, Inc
May 10, 2017 Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Pro... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing,... Class II ConvaTec, Inc
May 10, 2017 Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM Class II ConvaTec, Inc
May 10, 2017 Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL ... 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.