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Browse Device Recalls

590 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 590 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 590 FDA device recalls.

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DateProductReasonClassFirm
Jul 6, 2020 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoCla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, C... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(0... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, Mic... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotati... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave ST... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoCl... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit pe... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per p... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Cl... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per cas... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit p... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(0... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoC... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Dro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Ye... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotatin... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 p... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Re... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Val... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Ro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Cl... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 Micro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave R... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/R... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn,... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave C... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Base... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 un... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 u... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, 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.