Browse Device Recalls

432 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 432 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 432 FDA device recalls.

Clear

Date	Product	Reason	Class	Firm
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glov...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Oct 31, 2018	Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ...	Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm...	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double S...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, ...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, ...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref A...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref A...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single S...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref A...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Jun 11, 2018	Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref A...	The suction valve may not close properly which could cause continuous suction.	Class II	Cardinal Health 200, LLC
Mar 28, 2018	Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a)...	products may be missing a one-way valve on the fluid patient port.	Class II	Cardinal Health 200, LLC
Feb 20, 2018	Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML d...	A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li...	Class II	Cardinal Health 200, LLC
Feb 20, 2018	Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 50...	A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li...	Class II	Cardinal Health 200, LLC
Feb 20, 2018	Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric ...	A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li...	Class II	Cardinal Health 200, LLC
Feb 20, 2018	Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML dev...	A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li...	Class II	Cardinal Health 200, LLC
Aug 1, 2017	Presource(R) Kits (custom surgical/procedural kits): The standard and custom...	The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i...	Class II	Cardinal Health 200, LLC
Jul 28, 2017	Convertors Robotic Drape with Attached Leggings; Product is packaged as Singl...	Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.	Class II	Cardinal Health 200, LLC
Jun 27, 2017	Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STE...	Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ...	Class II	Cardinal Health 200, LLC
Jun 27, 2017	Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Car...	Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Si...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx ...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Si...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only....	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For ...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. ...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx ...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use O...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx ...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only....	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Sin...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use On...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use O...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use O...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For S...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single U...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Apr 21, 2017	Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Sin...	Product's seal possibly compromised, potentially compromising the sterility of the package conten...	Class II	Cardinal Health 200, LLC
Oct 6, 2016	The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla...	AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ...	Class II	AccessClosure, Inc., A Cardinal Health Company
Sep 23, 2016	V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, vario...	Potential risk associated with corrosion demonstrated on the distraction screw surface.	Class II	Cardinal Health 200, LLC
Jul 20, 2016	BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, ...	Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specif...	Class II	Cardinal Health
Jul 13, 2016	6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usa...	A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/pa...	Class II	AccessClosure, Inc., A Cardinal Health Company
Jun 27, 2016	The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sam...	Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as mi...	Class II	Cardinal Health

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.