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