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Browse Device Recalls

26 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 26 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 26 FDA device recalls.

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DateProductReasonClassFirm
Feb 5, 2026 Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog N... After receiving customer complaints, investigations confirmed the presence of a positive bias in ... Class II Diagnostica Stago, Inc.
Feb 4, 2026 Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protei... The potential of out-of-range results and an underestimation of the free protein S level in norma... Class II Diagnostica Stago, Inc.
Dec 15, 2025 Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit ... Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted... Class II Diagnostica Stago, Inc.
Sep 12, 2025 Product: STA Liatest D-Di; REF: 00515; A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. Class II Diagnostica Stago, Inc.
Jul 21, 2025 STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 k... Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... Class II Diagnostica Stago, Inc.
Jul 21, 2025 STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Ant... Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... Class II Diagnostica Stago, Inc.
Jul 21, 2025 STA Satellite. Product Code: All references. All software versions. The ST... Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... Class II Diagnostica Stago, Inc.
Jul 21, 2025 STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti... Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... Class II Diagnostica Stago, Inc.
May 21, 2025 STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a bu... Potential for shorter clotting times in clotting tests which have a dilution, leading to possible... Class II Diagnostica Stago, Inc.
Mar 22, 2023 STA R Max fully automatic clinical instrument designed to perform tests on hu... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 an... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and ... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 4, 2020 STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno... A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago inst... Class II Diagnostica Stago, Inc.
Nov 18, 2019 STA UNICALIBRATOR (ref. 00675) A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX... Class II Diagnostica Stago, Inc.
Nov 18, 2019 STA SYSTEM CONROL N + P (ref. 00678) A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX... Class II Diagnostica Stago, Inc.
Nov 14, 2018 Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are ... There have been reports of shortened (T1-T2) results, where some instances of result recovery out... Class II Diagnostica Stago, Inc.
Nov 14, 2018 Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits ar... There have been reports of shortened (T1-T2) results, where some instances of result recovery out... Class II Diagnostica Stago, Inc.
Jul 24, 2018 Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic... QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) Class II Diagnostica Stago, Inc.
Jul 24, 2018 Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for d... QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) Class II Diagnostica Stago, Inc.
Oct 25, 2017 Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated de... Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de... Class II Diagnostica Stago, Inc.
Oct 25, 2017 STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated d... Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de... Class II Diagnostica Stago, Inc.
Oct 25, 2017 Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated d... Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de... Class II Diagnostica Stago, Inc.
Oct 25, 2017 STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automa... Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (de... Class II Diagnostica Stago, Inc.
Jul 18, 2014 Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kit... Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (sub... Class III Diagnostica Stago, Inc.
Jan 28, 2013 Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATES... Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a ... Class II Diagnostica Stago, Inc.
Jun 15, 2012 STA Satellite Automated Multi-Parameter Analyzer This system is a fully au... Following a single customer complaint that incorrect INR values were occasionally printed for PT ... Class II Diagnostica Stago, 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.