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-0224-05 | Portex Hypodermic Needle-Pro 5 ml Syringe, 21g x 1 '' Needle Catalog Number: 4252 | Abbott Medical | FMJ | ||
| Z-0223-05 | Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1'' Needle Catalog Number: 4251 | Abbott Medical | FMJ | ||
| Z-0222-05 | Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1 '' Needle Catalog Number: 4250 | Abbott Medical | |||
| Z-0439-05 | The Hospira Plum A+3 I.V. Infusion pump is a cassette-based, multi-function fluid... | Abbott Medical | JFL | ||
| Z-0438-05 | The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery... | Abbott Medical | JFL | ||
| Z-1499-04 | Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000. | Revvity Health Sciences, Inc. | JIA | ||
| Z-1485-04 | The LTV Series ventilators provides continuous or intermittent ventilatory support for... | Pulmonetic Systems, Inc. | CBK | ||
| Z-0256-06 | Long Length Dyax Nail. | Howmedica Osteonics Corp | NDH | ||
| Z-0494-05 | X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray... | Canon Medical Systems USA, Inc. | rad | ||
| Z-0177-05 | Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by... | Medical Industries America, Inc. | CAF | ||
| Z-0326-05 | RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm... | Medical Industries America, Inc. | BZD | ||
| Z-1496-04 | Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher... | Fisher Diagnostics | GHM | ||
| Z-0012-05 | Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080... | GE Healthcare | KPS | ||
| Z-0004-05 | AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis... | AmeriWater LLC. | FIP | ||
| Z-0387-06 | LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935 | GE Healthcare | IYN | ||
| Z-0386-06 | LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477. | GE Healthcare | IYN | ||
| Z-0601-2007 | Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0600-2007 | Terumo Advanced Perfusion System 1, 4 inch diameter (small) Roller Pump; Model 801040. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0008-05 | Biliary Stent System (6Fr 9mm x 30mm). | Medtronic, Inc. | FGE | ||
| Z-1570-05 | Baxter Lock Box for 250 mL Container, for use with 6060 Pump Family; Baxter product code... | Baxter Healthcare Corporation | FRN | ||
| Z-1569-05 | Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter... | Baxter Healthcare Corporation | FRN | ||
| Z-1474-04 | XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma... | Abbott Medical | JJE | ||
| Z-0214-05 | Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a... | Zeus Scientific LLC | MID | ||
| Z-0022-05 | iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing... | Independence Technology, LLC | IMK | ||
| Z-0042-05 | DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro... | Siemens Healthcare Diagnostics Inc. | JPA | ||
| Z-1498-04 | Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and... | Abbott Medical | LOM | ||
| Z-0041-05 | Ultra Power Burs, Sterile, Single-Use. | Linvatec Corporation | HRX | ||
| Z-0273-05 | Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart... | Canon Medical Systems USA, Inc. | LNH | ||
| Z-0006-05 | AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 | Abbott Diagnostic International, Ltd. | JHI | ||
| Z-0040-05 | ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001... | Zimmer Spine, Inc. | KWQ | ||
| Z-1482-04 | Hill-Rom brand VersaCare Bed; Model P3200. | Hill-Rom Inc. | FNL | ||
| Z-1414-04 | The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System... | Medtronic, Inc. | CCK | ||
| Z-1334-04 | 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used... | Medtronic Neuromodulation | LKK | ||
| Z-1603-05 | BD Vacutainer Microtainer Serum tubes (with or without gel). | Becton Dickinson & Co | JKA | ||
| Z-1602-05 | BD Vacutainer Partial Draw serum tubes (with or without gel). | Becton Dickinson & Co | JKA | ||
| Z-0052-05 | BD Vactuainer SST glass and plastic tubes. | Becton Dickinson & Co | JKA | ||
| Z-0054-05 | Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969 | bioMerieux, Inc. | GJA | ||
| Z-0053-05 | MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969 | bioMerieux, Inc. | GJA | ||
| Z-1488-04 | NT Intera Magnetic Resonance Image System | Philips North America LLC | KRP | ||
| Z-1435-04 | Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P... | Roche Diagnostics GmbH | CIT | ||
| Z-1434-04 | Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P... | Roche Diagnostics GmbH | CKH | ||
| Z-1452-04 | ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott... | Abbott Medical | LIG | ||
| Z-0031-05 | Hem-o-lok Endo5 Ligation Applier | Teleflex Medical | HBT | ||
| Z-0570-05 | Flexiflo Quantum Enteral Pump | Ross Products Division Abbott Laboratories | LZH | ||
| Z-1156-06 | Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203... | Adept-Med Intl., Inc. | GZC | ||
| Z-0005-05 | Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047 | CooperSurgical, Inc. | HDB | ||
| Z-0023-05 | Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092. | Stryker Medical | FPO | ||
| Z-0129-06 | Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The... | KCI USA, Inc. | FNL | ||
| Z-1437-04 | Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog #... | Biosense Webster Inc | DRF | ||
| Z-0003-05 | Automated Differential Cell Counter | Horiba Instruments Incorporated | GKZ |