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
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
May 10, 2017	Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-...		Class II	ConvaTec, Inc
May 10, 2017	Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Pro...		Class II	ConvaTec, Inc
May 10, 2017	Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreat...		Class II	ConvaTec, Inc
May 10, 2017	Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Cod...	Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use we...	Class II	ConvaTec, Inc
May 10, 2017	Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, ...		Class II	ConvaTec, Inc
May 10, 2017	Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreath...		Class II	ConvaTec, Inc
May 10, 2017	Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2...		Class II	ConvaTec, Inc
May 10, 2017	Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing...		Class II	ConvaTec, Inc
May 10, 2017	Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreat...		Class II	ConvaTec, Inc
May 10, 2017	Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FIT...		Class II	ConvaTec, Inc
May 10, 2017	Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tu...		Class II	ConvaTec, Inc
May 9, 2017	Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,	Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult ...	Class II	Teleflex Medical
Apr 21, 2017	INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Acces...		Class II	Teleflex Medical
Apr 21, 2017	PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter C...	Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro...	Class II	Teleflex Medical

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.