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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 7, 2020 | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG P... | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, ... | Class II | Tosoh Bioscience Inc |
| Aug 7, 2020 | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Dia... | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, ... | Class II | Tosoh Bioscience Inc |
| May 22, 2020 | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 | The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle.... | Class II | Tosoh Bioscience Inc |
| Jan 10, 2020 | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | A display screen software issue on the analyzer causes the display to freeze when display screen ... | Class II | Tosoh Bioscience Inc |
| Nov 30, 2018 | AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for t... | Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh A... | Class II | Tosoh Bioscience Inc |
| Nov 30, 2018 | ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOS... | Class II | Tosoh Bioscience Inc | |
| Nov 30, 2018 | ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY f... | Class II | Tosoh Bioscience Inc | |
| Nov 30, 2018 | ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY f... | Class II | Tosoh Bioscience Inc | |
| Nov 30, 2018 | AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the qu... | Class II | Tosoh Bioscience Inc | |
| Nov 30, 2018 | ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO... | Class II | Tosoh Bioscience Inc | |
| Oct 5, 2018 | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Produ... | Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotati... | Class II | Tosoh Bioscience Inc |
| Oct 5, 2018 | AIA-900 Analyzer, Product code 022930, 022930R | Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor o... | Class II | Tosoh Bioscience Inc |
| Oct 5, 2018 | Hemoglobin A1c Control, Part no. 220232 for use as quality control material t... | Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the... | Class III | Tosoh Bioscience Inc |
| Sep 28, 2018 | Tosoh AIA-900 immunoassay Analyzer | A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AI... | There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AI... | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers th... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-... | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers th... | Class II | Tosoh Bioscience Inc |
| Aug 23, 2018 | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated... | The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These label... | Class II | Tosoh Bioscience Inc |
| Jul 13, 2018 | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use... | Analyzers were distributed with software which lacks a 510K | Class II | Tosoh Bioscience Inc |
| Jun 6, 2018 | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 ... | HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Cu... | Class II | Tosoh Bioscience Inc |
| Jun 5, 2018 | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027... | Distribution of unapproved product labeling | Class III | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone | 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 Pretreatment Solution, HbA1c Pretreatment Solution, P... | The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac 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 HCG; Part Number: 025256 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 C-Peptide II; Part Number: 025283 Assay, Diabetes | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK BMG; Part Number:025259 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 PAP; Part Number: 025262 Assay, Prostate | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK Estradiol; Part Number: 025274 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 cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac 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 TT3; Part Number: 025282 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid | 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 Calibrator, HbA1c Calibrator, PN 025318 The produc... | The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK hsE2; Part Number: 025225 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 C-Peptide; Part Number: 025284 Assay, Diabetes | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK AFP; Part Number: 025252 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 HGH; Part Number: 025266 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 TU; Part Number: 025270 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney 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, HbA1c Reagent, Pt. No. 025218 The device is desig... | The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | Tosoh Bioscience Inc |
| Mar 5, 2018 | ST-AIA DHEA-S; Part Number: 025222 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 LH II; Part Number: 025296 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 27.29; Part Number: 025202 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 CK-MB; Part Number: 025269 Assay, Cardiac 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 Prog II; Part Number: 025239 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 CEA; Part Number: 025254 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 T4; Part Number: 025258 Assay, Thyroid | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... | Class II | 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.