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Browse Device Recalls

33 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 33 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 33 FDA device recalls.

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DateProductReasonClassFirm
Oct 9, 2024 SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-u... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-us... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-us... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An e... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An e... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-us... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-us... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) ... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadia... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Conne... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) ... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Conne... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadia... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadia... Potential for leaking product Class II The Metrix Company
Sep 21, 2018 SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) ... Potential for leaking product Class II The Metrix Company
Sep 13, 2017 SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 587... The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The ... Class II The Metrix Company
Jun 23, 2016 Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2... An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 Container fill and transfer sets, 250 mL and 500 mL, . . An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 125... An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, ... An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, ... An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 AUTOCOMP6 XP High Speed Compounder REF 58810 An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 AUTOCOMP6 High Speed Compounder An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company
Jun 23, 2016 AUTOCOMP6 XPS High Speed Compounder REF 58810 An issue was identified after a redesign of the auto compounding device. The compounder cannot me... Class II The Metrix Company

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.