Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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Date	Product	Reason	Class	Firm
Oct 23, 2017	Surgical punch; sealed pouches packed in punch shelf box Intended for use...	Surgical punches are being recalled due to potential packaging damage which may have occurred dur...	Class II	Alto Development Corp
Oct 23, 2017	SorbaView Shield Dressing Change Tray	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	MINI PLASTICS SET	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pou...	Possible open seal on top portion of the package. Could cause breach of sterility.	Class II	Medline Industries Inc
Oct 23, 2017	Disposable Curved Circular Staplers Product Usage: Staplers have applicat...	There is a potential for the devices to create staples that do not meet formed staple height spec...	Class II	Ethicon Endo-Surgery Inc
Oct 23, 2017	INFANT IV SECUREMENT KIT	Convenience Kit containing components to assist practitioner with IV placement and securement.	Class II	Centurion Medical Products Corporation
Oct 23, 2017	IV START KIT	Convenience Kit containing components to assist practitioner with IV placement and securement.	Class II	Centurion Medical Products Corporation
Oct 23, 2017	NEONATAL IV START KIT	Convenience Kit containing components to assist practitioner with IV placement and securement.	Class II	Centurion Medical Products Corporation
Oct 23, 2017	CATHETER SECUREMENT SYSTEM	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.	The expiration date provided on the label is incorrect.	Class II	Smith & Nephew, Inc.
Oct 23, 2017	LATEX FREE IV START SET	Convenience Kit containing components to assist practitioner with IV placement and securement.	Class II	Centurion Medical Products Corporation
Oct 23, 2017	SUTURE REMOVAL TRAY, SET or KIT	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	GENERAL PURPOSE INSTRUMENT TRAY	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 23, 2017	NEONATAL IV ACCESS SET	Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine as...	Class II	Centurion Medical Products Corporation
Oct 20, 2017	HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx O...	The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ...	Class II	Terumo BCT, Inc.
Oct 20, 2017	Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with ...	The ultrasound probe may not have adequate protection against electrical shock hazards.	Class II	Hitachi Medical Systems America Inc
Oct 20, 2017	Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat tr...	Potential breach of sterility of the packaging.	Class II	Shippert Medical Technologies
Oct 20, 2017	HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice...	The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ...	Class II	Terumo BCT, Inc.
Oct 20, 2017	HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO...	Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a sea...	Class II	Terumo BCT, Inc.
Oct 19, 2017	BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 70...	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnos...	The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with ...	Class II	Philips Electronics North America Corporation
Oct 19, 2017	BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 70...	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the ...	Cook has identified that the affected lots may contain wire guides that were loaded backwards int...	Class II	Cook Inc.
Oct 19, 2017	BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses	Some contact lenses were associated with complaints of a foreign matter caught between the bliste...	Class II	Johnson & Johnson Vision Care, Inc.
Oct 19, 2017	BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067...	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 22701, Catalog No. 701050790	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	Percutaneous Gastrojejunostomy Set Product Usage: Intended for the perc...	Cook has identified that the affected lots may contain wire guides that were loaded backwards int...	Class II	Cook Inc.
Oct 19, 2017	ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog...	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS	Some contact lenses were associated with complaints of a foreign matter caught between the bliste...	Class II	Johnson & Johnson Vision Care, Inc.
Oct 19, 2017	BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513	The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma...	Class II	Datascope Corporation
Oct 19, 2017	Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Inte...	Cook has identified that the affected lots may contain wire guides that were loaded backwards int...	Class II	Cook 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.