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-1138-2018 | Class II | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541... | Esaote S.p.A. | IYN | |
| Z-1137-2018 | Class II | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 | Esaote S.p.A. | IYN | |
| Z-1172-2018 | Class II | HEMASHIELD Knitted Double Velour Cardiovascular Fabric | Getinge US Sales LLC | DXZ | |
| Z-0939-2018 | Class II | Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01)... | Zimmer GmbH | LPH | |
| Z-0840-2018 | Class II | Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product... | Philips North America LLC | JAK | |
| Z-0839-2018 | Class II | Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product... | Philips North America LLC | JAK | |
| Z-0776-2018 | Class II | Intellivue iX Information Center Software - All PIIC iX Surveillance stations... | Philips North America LLC | MHX | |
| Z-0535-2018 | Class II | Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit... | Medtronic Perfusion Systems | DWF | |
| Z-1519-2018 | Class II | Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra... | Roche Diagnostics GmbH | LDP | |
| Z-1691-2018 | Class II | IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3) | Siemens Healthcare Diagnostics Inc. | MOI | |
| Z-1690-2018 | Class II | ADVIA Centaur HBc IgM | Siemens Healthcare Diagnostics Inc. | LOM | |
| Z-1689-2018 | Class II | ADVIA Centaur Folate (FOL) | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-1688-2018 | Class II | ADVIA Centaur DHEA-SO4 | Siemens Healthcare Diagnostics Inc. | JKC | |
| Z-1687-2018 | Class II | ADVIA Centaur Cyclosporine | Siemens Healthcare Diagnostics Inc. | MKW | |
| Z-1686-2018 | Class II | IMMULITE /IMMULITE 1000 Vitamin B12 | Siemens Healthcare Diagnostics Inc. | CDD | |
| Z-1685-2018 | Class II | IMMULITE 2000/IMMULITE 2000 XPi TG | Siemens Healthcare Diagnostics Inc. | MSW | |
| Z-1684-2018 | Class II | Immulite /Immulite 1000 Tg | Siemens Healthcare Diagnostics Inc. | MSW | |
| Z-1683-2018 | Class II | IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125) | Siemens Healthcare Diagnostics Inc. | LTK | |
| Z-1682-2018 | Class II | Immulite /Immulite 1000 Om-Ma (Ca125) | Siemens Healthcare Diagnostics Inc. | LTK | |
| Z-1681-2018 | Class II | IMMULITE 2000/IMMULITE 2000 XPi Gastrin | Siemens Healthcare Diagnostics Inc. | CGC | |
| Z-1680-2018 | Class II | IMMULITE /IMMULITE 1000 Gastrin | Siemens Healthcare Diagnostics Inc. | CGC | |
| Z-1679-2018 | Class II | IMMULITE 2000/IMMULITE 2000 XPi CEA | Siemens Healthcare Diagnostics Inc. | DHX | |
| Z-1678-2018 | Class II | Immulite /Immulite 1000 Cea | Siemens Healthcare Diagnostics Inc. | DHX | |
| Z-1677-2018 | Class II | Immulite /Immulite 1000 Br-Ma (Ca15-3) | Siemens Healthcare Diagnostics Inc. | MOI | |
| Z-1676-2018 | Class II | IMMULITE 2000/IMMULITE 2000 XPi Folic Acid | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-1675-2018 | Class II | IMMULITE 2000/IMMULITE 2000 XPi Anti HBc | Siemens Healthcare Diagnostics Inc. | LOM | |
| Z-1674-2018 | Class II | IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit | Siemens Healthcare Diagnostics Inc. | DHB | |
| Z-1673-2018 | Class II | Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-1672-2018 | Class II | Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | JHY | |
| Z-1671-2018 | Class II | Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-1670-2018 | Class II | Dimension Sirolimus (SIRO) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | NRP | |
| Z-1669-2018 | Class II | Dimension Free Thyroxine (FT4L) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | CEC | |
| Z-1668-2018 | Class II | Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-0917-2018 | Class II | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP... | Stryker Sustainability Solutions | NLH | |
| Z-0916-2018 | Class II | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP... | Stryker Sustainability Solutions | NLH | |
| Z-0845-2018 | Class II | INFX-8000H Fluoroscopic X-Ray Systems | Canon Medical Systems USA, Inc. | JAA | |
| Z-0844-2018 | Class II | INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM | Canon Medical Systems USA, Inc. | OWB | |
| Z-0843-2018 | Class II | INFX-8000C Fluoroscopic X-Ray Systems | Canon Medical Systems USA, Inc. | OWB | |
| Z-0842-2018 | Class II | INFX-8000F Fluoroscopic X-Ray Systems | Canon Medical Systems USA, Inc. | MBQ | |
| Z-2313-2021 | Class II | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile | Epimed International, Inc. | BSO | |
| Z-2312-2021 | Class II | NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile | Epimed International, Inc. | BSO | |
| Z-2517-2018 | Class II | 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular... | implantcast GmbH | LZO | |
| Z-1602-2018 | Class II | HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a)... | Southwest Technologies Inc | N/A | |
| Z-1601-2018 | Class II | HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a)... | Southwest Technologies Inc | N/A | |
| Z-0536-2018 | Class II | PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a... | Bard Access Systems, Inc. | LJS | |
| Z-1600-2018 | Class II | HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a)... | Southwest Technologies Inc | N/A | |
| Z-3182-2018 | Class II | Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog #... | Mako Surgical Corp. | OLO | |
| Z-0578-2018 | Class II | EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1... | Little Rapids Corporation | KME | |
| Z-0413-2018 | Class II | Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an... | Ormco/Sybronendo | EKR | |
| Z-1336-2018 | Class II | ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MPB |