Browse Device Recalls

68 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 68 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 68 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 5, 2018 ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is i... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Feb 13, 2018 ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239 Falsely elevated progesterone assay values will occur when using certain progesterone assay part ... Class II Tosoh Bioscience Inc
Feb 13, 2018 ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240 Falsely elevated progesterone assay values will occur when using certain progesterone assay part ... Class II Tosoh Bioscience Inc
Sep 28, 2017 AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay... The firm has become aware of a potential issue that may affect the mixing motor drive harness and... Class II Tosoh Bioscience Inc
Jun 11, 2017 Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code ... This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The ... Class II Tosoh Bioscience Inc
Jun 11, 2017 Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 0229... This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The ... Class II Tosoh Bioscience Inc
Mar 22, 2017 AIA-360 Analyzer is capable of performing two methods of immunoassay: an immu... The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the t... Class II Tosoh Bioscience Inc
Feb 23, 2012 Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VI... Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, ... Class II Tosoh Bioscience Inc
Aug 18, 2010 G7 HPLC. Used as an aid in the detection and presumptive identification of... The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performan... Class III Tosoh Bioscience 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.