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Browse Device Recalls

69 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 69 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 69 FDA device recalls.

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DateProductReasonClassFirm
Jun 3, 2014 ACL TOP (Base), automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP 500 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Nov 15, 2013 HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class II Instrumentation Laboratory Co.
Nov 15, 2013 HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class II Instrumentation Laboratory Co.
Nov 15, 2013 HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class II Instrumentation Laboratory Co.
Jul 19, 2013 ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access a... Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class II Instrumentation Laboratory Co.
Jul 19, 2013 ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access a... Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class II Instrumentation Laboratory Co.
Jul 19, 2013 ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully au... Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class II Instrumentation Laboratory Co.
Jul 19, 2013 ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access a... Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class II Instrumentation Laboratory Co.
Jul 19, 2013 ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analy... Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class II Instrumentation Laboratory Co.
Jul 19, 2013 ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analy... Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class II Instrumentation Laboratory Co.
Jul 19, 2013 ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access an... Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class II Instrumentation Laboratory Co.
Apr 9, 2013 HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is... Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8... Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench t... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench ... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a benc... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.

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.