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Browse Device Recalls

44 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 44 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 44 FDA device recalls.

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DateProductReasonClassFirm
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Apr 26, 2019 SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR... There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... Class I Terumo Medical Corporation
Apr 26, 2019 Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSO... There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... Class I Terumo Medical Corporation
Apr 26, 2019 SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, S... There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... Class I Terumo Medical Corporation
Feb 8, 2019 Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Needle, 30G x 1/2", Product Code NN3013R There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Needle, 18G x 1", Product Code NN1825R There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Sur-vet Needle, 22G x 1", Product Code 100211 There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Sur-vet Needle, 20G x 1", Product Code 100204 There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Needle, 23G x 1", Product Code NN2325R There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Apr 9, 2018 Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 Two lots of product were released for distribution prior to the completion of all required valida... Class II Terumo Medical Corp
Sep 12, 2017 Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Prod... The tucking depth feature of this catheter introducer is marginally outside the upper specification. Class II Terumo Medical Corporation
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Aug 4, 2016 MISAGO RX Self Expanding Peripheral Stem During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product sp... Class II Terumo Medical Corp
Mar 16, 2016 PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNAC... Terumo Medical is initiating this recall due to complaints of valve leakage that have been relate... Class II Terumo Medical Corporation
Nov 23, 2015 Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshiel... Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion S... Class II Terumo Medical Corp
Nov 6, 2015 Destination Renal Guiding Sheath Intended for the introduction of interven... Based on internal investigation and testing that revealed the distal end of certain lots of Terum... Class II Terumo Medical Corporation
Aug 5, 2015 SurFlo IV Catheter According to the Terumo (TMC) this device is used to access the human peripheral vascular system ... Class II Terumo Medical Corporation
May 30, 2013 Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Use... Medical devices were incorrectly labeled with extended expiration dates. Class II Terumo Medical Corporation
May 30, 2013 Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Ti... Medical devices were incorrectly labeled with extended expiration dates. Class II Terumo Medical Corporation

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.