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Browse Device Recalls

20 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 20 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 20 FDA device recalls.

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DateProductReasonClassFirm
Mar 1, 2018 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotatin... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Cl... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Ch... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Cle... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotati... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.

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.