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-0512-04 | 50 mL sterile plastic centerfuge tubes. | Stockwell Scientific Inc | JKA | ||
| Z-0337-04 | Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591. | Roche Diagnostics GmbH | JJE | ||
| Z-0336-04 | Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R. | Roche Diagnostics GmbH | JJE | ||
| Z-0335-04 | Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R. | Roche Diagnostics GmbH | JJE | ||
| Z-0334-04 | Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591. | Roche Diagnostics GmbH | JJE | ||
| Z-0333-04 | Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R. | Roche Diagnostics GmbH | JJE | ||
| Z-0332-04 | Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R . | Roche Diagnostics GmbH | JJE | ||
| Z-0331-04 | Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591. | Roche Diagnostics GmbH | JJE | ||
| Z-0330-04 | Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R. | Roche Diagnostics GmbH | JJE | ||
| Z-0329-04 | Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R. | Roche Diagnostics GmbH | JJE | ||
| Z-0338-04 | Hill-Rom brand Century+ bed; model P1400. | Hill-Rom Inc. | FNL | ||
| Z-0535-04 | Esaote brand Formul@ ECG System; part 9704220000. | Esaote Biomedica SpA | DPS | ||
| Z-0534-04 | Esaote brand ArchiWin Colour ECG System; part 9704325000. | Esaote Biomedica SpA | DPS | ||
| Z-0520-04 | Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone... | Laerdal Medical a/S | BTM | ||
| Z-0519-04 | LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve... | Laerdal Medical a/S | BTM | ||
| Z-0518-04 | LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir... | Laerdal Medical a/S | BTM | ||
| Z-0533-04 | Esaote brand Formula for Archimed ECG System; part 9704220000. | Esaote Biomedica SpA | DPS | ||
| Z-0517-04 | LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold... | Laerdal Medical a/S | BTM | ||
| Z-0532-04 | Esaote brand Archimed 4220 ECG System; part 9704220000. | Esaote Biomedica SpA | DPS | ||
| Z-1370-04 | P.F.C. Knee System 7 Fluted Femoral Stem 18mmX130mm REF: 96-1731 | Depuy Orthopaedics Inc. | JWH | ||
| Z-1369-04 | P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703 | Depuy Orthopaedics Inc. | JWH | ||
| Z-0355-04 | Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30. | Abbott Medical | JGJ | ||
| Z-0374-04 | ICON 25 hCG test kit. | Siemens Healthcare Diagnostics Inc. | JHI | ||
| Z-0347-04 | Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent... | Wilson-Cook Medical Inc. | FGE | ||
| Z-0315-04 | Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only... | C.R. Bard Inc | FFL | ||
| Z-0314-04 | Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014 | C.R. Bard Inc | FFL | ||
| Z-0588-04 | EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6... | Shelhigh, Inc. | GXQ | ||
| Z-0356-04 | Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100 | Access Cardiosystems, Inc. | MKJ | ||
| Z-0303-04 | Hill-Rom Newborn bassinet; model P248. | Hill-Rom Inc. | FMS | ||
| Z-0302-04 | Hill-Rom Newborn bassinet; model P247. | Hill-Rom Inc. | FMS | ||
| Z-0522-04 | Magnetom Allegra System. Nuclear Magnetic Resonance Imaging Diagnostic Device | Siemens Medical Solutions USA, Inc. | |||
| Z-0521-04 | Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1152-04 | Array Systems Calibrator 5 Part No. 465250 | Siemens Healthcare Diagnostics Inc. | GTQ | ||
| Z-0543-04 | 18 Gauge thin wall needle as part of a Central Venous Catheter Kit | Abbott Medical | FOZ | ||
| Z-0549-04 | VACUTAINER Brand Push Button Blood Collection Sets. | Becton Dickinson & Co | JKA | ||
| Z-0376-04 | Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an... | Baxter Healthcare Corporation | FRN-- | ||
| Z-0375-04 | Cidex Plus Test Strips | Advanced Sterilization Products | JOJ | ||
| Z-0301-04 | Howell D.A.S.H. II Access System, Wire Guided Sphincterotome | Wilson-Cook Medical Inc. | KNS | ||
| Z-0977-04 | Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas | Mentor | FTN | ||
| Z-0388-04 | Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA... | Greiner Bio-One North America, Inc. | FPA | ||
| Z-0372-04 | IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate... | Abbott Medical | CGN-- | ||
| Z-0371-04 | IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with... | Abbott Medical | CGN-- | ||
| Z-0370-04 | IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of... | Abbott Medical | CGN-- | ||
| Z-0369-04 | IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate... | Abbott Medical | CGN-- | ||
| Z-0368-04 | Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for... | Abbott Medical | CGN-- | ||
| Z-0367-04 | AxSYM Folate Medium Control Pack , list 3C81-11, the pack contains 8 - 1 mL vials of... | Abbott Medical | CGN-- | ||
| Z-0366-04 | AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human... | Abbott Medical | CGN-- | ||
| Z-0365-04 | AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with... | Abbott Medical | CGN-- | ||
| Z-0377-04 | Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode... | Baxter Healthcare Corporation | LHI-- | ||
| Z-0364-04 | ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests)... | Abbott Medical | CGN-- |