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Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

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DateProductReasonClassFirm
Aug 19, 2025 Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator ... Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel sepa... Class II Greiner Bio-One North America, Inc.
Aug 8, 2025 Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 Blood collection tubes were manufactured with the label applied too high on the tube, which shif... Class II Greiner Bio-One North America, Inc.
May 14, 2024 VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow... The firm received reports that some blood collection tubes have experienced issues with clotting ... Class II Greiner Bio-One North America, Inc.
Dec 12, 2023 VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 ... Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clott... Class II Greiner Bio-One North America, Inc.
Mar 31, 2023 greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, no... Some of the tubes may be incorrectly labeled. Class II Greiner Bio-One North America, Inc.
Dec 9, 2021 greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-... Some of the blood collection tubes show clotting due to variation of Lithium Heparin. Class II Greiner Bio-One North America, Inc.
Aug 20, 2021 Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75... Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. Class II Greiner Bio-One North America, Inc.
Aug 13, 2021 VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged Blood collection tubes may experience a clotting issue. Class II Greiner Bio-One North America, Inc.
Mar 29, 2021 VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blu... VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw vo... Class II Greiner Bio-One North America, Inc.
Aug 28, 2020 VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P -... Blood collection tubes experienced an issue with separation and clotting Class II Greiner Bio-One North America, Inc.
Mar 12, 2020 VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot n... Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the... Class II Greiner Bio-One North America, Inc.
Nov 25, 2019 VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usag... The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. ... Class II Greiner Bio-One North America, Inc.
Apr 26, 2016 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolyt... The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride a... Class II Greiner Bio-One North America, Inc.
Feb 1, 2013 VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Coll... The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) duri... Class II Greiner Bio-One North America, Inc.
Jul 2, 2012 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North... Part of the lot received a lower concentration of citrate solution which may cause falsely lower ... Class II Greiner Bio-One North America, Inc.
Apr 2, 2012 Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. ... : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green ... Class II Greiner Bio-One North America, 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.