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-0002-05 | Automated Differential Cell Counter | Horiba Instruments Incorporated | GKZ | ||
| Z-1433-04 | COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1104-2007 | american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica... | Louisville Apl Diagnostics Inc | MID | ||
| Z-1103-2007 | american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica... | Louisville Apl Diagnostics Inc | MID | ||
| Z-1450-04 | Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 656 | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-1449-04 | Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649 | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-1438-04 | Optima Spinal System and Spinal Hook System, set screw component. | U&I America | MNI | ||
| Z-1413-04 | ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as... | ConMed Corporation | GEI | ||
| Z-1412-04 | ConMed Stealth Coated Laparoscopic Electrodes with 3/32'' pin (60-5158 series) as... | ConMed Corporation | GEI | ||
| Z-1445-04 | Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm... | Boston Scientific Corporation | KNW | ||
| Z-1444-04 | Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22... | Boston Scientific Corporation | KNW | ||
| Z-1443-04 | Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat... | Boston Scientific Corporation | KNW | ||
| Z-1442-04 | Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge... | Boston Scientific Corporation | KNW | ||
| Z-1432-04 | Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680. | Roche Diagnostics GmbH | JJE | ||
| Z-1431-04 | Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number... | Roche Diagnostics GmbH | JJE | ||
| Z-1497-04 | Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups... | Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst. | FMF | ||
| Z-1371-04 | MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. | Roche Diagnostics GmbH | NPQ | ||
| Z-1430-04 | Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number... | Roche Diagnostics GmbH | JJE | ||
| Z-1429-04 | Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number... | Roche Diagnostics GmbH | JJE | ||
| Z-1428-04 | Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680. | Roche Diagnostics GmbH | JJE | ||
| Z-1471-04 | Laryngectomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item... | Premier Dental Products Co | JOH | ||
| Z-1470-04 | Laryngectomy Tubes, Air Lon Nylon, item number1050170 size 8 and item number 1050172 size... | Premier Dental Products Co | JOH | ||
| Z-1469-04 | Laryngectomy Tubes, Jackson Improved Stainless Steel, item number1037414 size 4, item... | Premier Dental Products Co | JOH | ||
| Z-1468-04 | Laryngectomy Tubes, Jackson Original Stainless Steel, item number 1037214 size 4, item... | Premier Dental Products Co | JOH | ||
| Z-1467-04 | Laryngectomy Tubes, Martin Stainless Steel, item number 1036128 size 8 and item number... | Premier Dental Products Co | JOH | ||
| Z-1466-04 | Tracheostomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item... | Premier Dental Products Co | JOH | ||
| Z-1465-04 | Tracheostomy Tubes, Air Lon Nylon, item number 1050150 size 3, item number 1050152 size... | Premier Dental Products Co | JOH | ||
| Z-1464-04 | Tracheostomy Tubes, Jackson Improved Extra Long Stainless Steel, item number 1034964 size... | Premier Dental Products Co | JOH | ||
| Z-1463-04 | Tracheostomy Tubes, Jackson Improved Short Stainless Steel with Adapter, item number... | Premier Dental Products Co | JOH | ||
| Z-1462-04 | Tracheostomy Tubes, Jackson Improved Short Stainless Steel, item number 1034930 size 00... | Premier Dental Products Co | JOH | ||
| Z-1461-04 | Tracheostomy Tubes, Jackson Improved Stainless Steel with Adapter, item number 8100465... | Premier Dental Products Co | JOH | ||
| Z-1460-04 | Tracheostomy Tubes, Jackson Improved Stainless Steel, item number 1034900 size 00, item... | Premier Dental Products Co | JOH | ||
| Z-1459-04 | Tracheostomy Tubes, Jackson Original Short Stainless Steel, item number 1034600 size 00... | Premier Dental Products Co | JOH | ||
| Z-1458-04 | Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item... | Premier Dental Products Co | JOH | ||
| Z-1424-04 | Allegiance Laminated Crutch Accessories, item 74152-110, Allegiance Crutch Hand Grip... | Duro-Med Industries, Inc. | INP | ||
| Z-1423-04 | Allegiance Laminated Crutch Accessories, item 74152-060, Allegiance Crutch Tips, 3/4'' x... | Duro-Med Industries, Inc. | INP | ||
| Z-1422-04 | Allegiance Laminated Crutch Accessories, item 74152-010, Allegiance Crutch Underarm Pad... | Duro-Med Industries, Inc. | INP | ||
| Z-1421-04 | Allegiance Laminated Wood Crutches, item 74151-050, Child - 28'' - 36''; 1 pair... | Duro-Med Industries, Inc. | IPR | ||
| Z-1420-04 | Allegiance Laminated Wood Crutches, item 74151-040, Youth - 35'' - 43''; 1 pair... | Duro-Med Industries, Inc. | IPR | ||
| Z-1419-04 | Allegiance Laminated Wood Crutches, item 74151-030, Medium - 43'' - 53''; 1 pair... | Duro-Med Industries, Inc. | IPR | ||
| Z-1418-04 | Allegiance Laminated Wood Crutches, item 74151-020, Adult - 47'' - 57''; 1 pair... | Duro-Med Industries, Inc. | IPR | ||
| Z-1426-04 | Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece... | Abbott Medical | DYB | ||
| Z-1425-04 | Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece... | Abbott Medical | DYB | ||
| Z-1417-04 | Allegiance Laminated Wood Crutches, item 74151-010, Large Adult - 51'' - 64''; 1 pair... | Duro-Med Industries, Inc. | IPR | ||
| Z-1381-04 | Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and... | Medibo N.V. | FSA | ||
| Z-1448-04 | Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat... | Zimmer GmbH | KRO | ||
| Z-1447-04 | Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat... | Zimmer GmbH | KRO | ||
| Z-1472-04 | Zoll M Series Automated Defibrillator (AED) | ZOLL Medical Corporation | MKT | ||
| Z-0889-06 | Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and... | Philips North America LLC | LLZ | ||
| Z-1409-04 | Peritoneal Lavage Kits, Model number AK-09001 | Arrow International LLC (subsidiary of Teleflex Incorporated) | GBW |