Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0160-2020 | Class II | Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For... | Siemens Medical Solutions USA, Inc. | MUE | |
| Z-0043-2020 | Class II | Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c... | Roche Diagnostics GmbH | LEH | |
| Z-0042-2020 | Class II | Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c... | Roche Diagnostics GmbH | LEH | |
| Z-0831-2020 | Class II | Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-0830-2020 | Class II | Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-0829-2020 | Class II | Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-2433-2019 | Class II | Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. | Getinge US Sales LLC | BSF | |
| Z-2494-2019 | Class II | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS... | Zeus Scientific LLC | N/A | |
| Z-2293-2019 | Class II | DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF... | DeRoyal Industries, Inc. | FPD | |
| Z-2207-2020 | Class II | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile... | Nobel Biocare USA LLC | NHA | |
| Z-1148-2020 | Class II | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI... | Stryker Corp. | MBI | |
| Z-1147-2020 | Class II | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472... | Stryker Corp. | MBI | |
| Z-2442-2019 | Class II | AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161 | Boston Scientific Corporation | EZY | |
| Z-2495-2019 | Class II | Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product... | Philips North America LLC | DSA | |
| Z-2441-2019 | Class II | Fujifilm FDR Go Plus mobile X-ray system | FUJIFILM Healthcare Americas Corporation | IZL | |
| Z-2347-2019 | Class II | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. | Aniara Diagnostica LLC | LCO | |
| Z-2346-2019 | Class II | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | Aniara Diagnostica LLC | LCO | |
| Z-2206-2019 | Class II | Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and... | Integra LifeSciences Corporation | GEI | |
| Z-0117-2020 | Class II | Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4... | GE Healthcare | BSZ | |
| Z-0116-2020 | Class II | Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-0... | GE Healthcare | BSZ | |
| Z-0115-2020 | Class II | Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d)... | GE Healthcare | CBK | |
| Z-0114-2020 | Class II | Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d)... | GE Healthcare | BSZ | |
| Z-2436-2019 | Class II | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F | Coltene /Whaledent AG | EJL | |
| Z-2291-2019 | Class III | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a... | Gentherm Medical, LLC | ILO | |
| Z-0273-2020 | Class II | Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with... | Thermo Fisher Scientific (Monterrey) | FMH | |
| Z-0272-2020 | Class II | Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75... | Thermo Fisher Scientific (Monterrey) | FMH | |
| Z-2478-2019 | Class II | cobas c513 Analyzer | Roche Diagnostics GmbH | JJE | |
| Z-2477-2019 | Class II | Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers... | Roche Diagnostics GmbH | JJE | |
| Z-2476-2019 | Class II | cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 | Roche Diagnostics GmbH | JJE | |
| Z-0192-2020 | Class II | Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2082-2019 | Class II | IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear... | 3C-Medical Intelligence GmbH | IYE | |
| Z-0264-2020 | Class II | Petfine Auto Injector, REF 3310VET | Owen Mumford USA, Inc. | KZH | |
| Z-0263-2020 | Class II | Autoject EI, REF AJ1310 | Owen Mumford USA, Inc. | KZH | |
| Z-2339-2019 | Class II | Kit BD Max Enteric Viral Panel EU Catalog # 443985 | Becton Dickinson & Co | PCH | |
| Z-2338-2019 | Class II | Kit EXT Enteric Bacterial Panel; Catalog # 443812 | Becton Dickinson & Co | PCH | |
| Z-2337-2019 | Class II | Kit BD Max Enteric Viral Panel RUO; Catalog # 443715 | Becton Dickinson & Co | N/A | |
| Z-2336-2019 | Class II | Kit BD Max Vaginal Panel; Catalog # 443712 | Becton Dickinson & Co | PQA | |
| Z-2335-2019 | Class II | Kit BD Max GC RT PCR Assay; Catalog # 443486 | Becton Dickinson & Co | N/A | |
| Z-2334-2019 | Class II | Kit BD Max MRSA XT; Catalog # 443461 | Becton Dickinson & Co | NQX | |
| Z-2333-2019 | Class II | Kit BD Max StaphSR; Catalog # 443419 | Becton Dickinson & Co | NQX | |
| Z-2332-2019 | Class II | Kit BD Max StaphSR; Catalog # 443418 | Becton Dickinson & Co | NQX | |
| Z-2331-2019 | Class II | Kit BD Max CT/GC/TV; Catalog # 442970 | Becton Dickinson & Co | OUY | |
| Z-2330-2019 | Class II | Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963 | Becton Dickinson & Co | PCH | |
| Z-2329-2019 | Class II | Kit BD Max Enteric Parasite Panel EU; Catalog # 442960 | Becton Dickinson & Co | PCH | |
| Z-2328-2019 | Class II | Kit BD Max MRSA; Catalog # 442953 | Becton Dickinson & Co | NQX | |
| Z-2327-2019 | Class II | Kit BD Max ExK TNA 2; Catalog # 442825 | Becton Dickinson & Co | JJH | |
| Z-2326-2019 | Class II | Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820 | Becton Dickinson & Co | N/A | |
| Z-2325-2019 | Class II | Kit BD Max ExK DNA 2 USA; Catalog # 442819 | Becton Dickinson & Co | JJH | |
| Z-2324-2019 | Class II | Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818 | Becton Dickinson & Co | N/A | |
| Z-2323-2019 | Class II | Kit BD Max ExK DNA 1 USA; Catalog # 442817 | Becton Dickinson & Co | JJH |