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-1013-03 | Discovery II Multiprogrammable Pacemaker, Model 1184 | Boston Scientific Corporation | DXY | ||
| Z-1012-03 | Discovery II Multiprogrammable Pacemaker, Model 0981 | Boston Scientific Corporation | DXY | ||
| Z-1011-03 | Discovery II Multiprogrammable Pacemaker, Model 0481 | Boston Scientific Corporation | DXY | ||
| Z-1000-03 | Zoll M Series External Defibrillator | ZOLL Medical Corporation | MKJ | ||
| Z-1010-03 | Pulsar Max II Multiprogrammable Pacemaker, Model 1181 | Boston Scientific Corporation | DXY | ||
| Z-1009-03 | Pulsar Max II Multiprogrammable Pacemaker, Model 1180 | Boston Scientific Corporation | DXY | ||
| Z-0980-03 | Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software | Abbott Medical | FRN | ||
| Z-1028-03 | Hill-Rom Newborn bassinet; model P248 | Hill-Rom Inc. | |||
| Z-1027-03 | Hill-Rom Newborn bassinet; model P247 | Hill-Rom Inc. | |||
| Z-1077-03 | Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with... | Siemens Healthcare Diagnostics Inc. | |||
| Z-0911-03 | Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and... | Medrad, Inc. | |||
| Z-1148-03 | Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29 | Siemens Healthcare Diagnostics Inc. | KLS | ||
| Z-1039-03 | Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog... | Abbott Medical | BTO | ||
| Z-1290-03 | Stanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255 | Zimmer GmbH | JDI | ||
| Z-1289-03 | Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254 | Zimmer GmbH | JDI | ||
| Z-1288-03 | Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253 | Zimmer GmbH | JDI | ||
| Z-1287-03 | Stanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252 | Zimmer GmbH | JDI | ||
| Z-1286-03 | Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251 | Zimmer GmbH | JDI | ||
| Z-1285-03 | Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245 | Zimmer GmbH | JDI | ||
| Z-1284-03 | Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244 | Zimmer GmbH | JDI | ||
| Z-1283-03 | Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243 | Zimmer GmbH | JDI | ||
| Z-1282-03 | Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242 | Zimmer GmbH | JDI | ||
| Z-1281-03 | Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241 | Zimmer GmbH | JDI | ||
| Z-1053-03 | LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4... | LMA North America Inc | CAE | ||
| Z-1127-03 | Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers... | Meridian Bioscience Inc | LFZ | ||
| Z-0105-04 | Product is packed in plastic Tyvek packaging and is labeled as sterile as follows... | Exactech, Inc. | HTZ | ||
| Z-1006-03 | EBI VueCath Endoscopic Spinal System | Ebi, LLC | GWG | ||
| Z-1090-03 | Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module | CliniSys, Inc | JQP | ||
| Z-1008-03 | Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single) | Sanarus Medical, Inc. | |||
| Z-1005-03 | Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420 | Mitek Worldwide | |||
| Z-1004-03 | Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325 | Mitek Worldwide | |||
| Z-1138-03 | Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1064-03 | Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s... | GE Healthcare | 80FMZ | ||
| Z-1085-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For... | Ballard Medical Products | BSY | ||
| Z-1084-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For... | Ballard Medical Products | BSY | ||
| Z-1083-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates | Ballard Medical Products | BSY | ||
| Z-1082-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates | Ballard Medical Products | BSY | ||
| Z-1081-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates | Ballard Medical Products | BSY | ||
| Z-1080-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates | Ballard Medical Products | BSY | ||
| Z-1079-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. | Ballard Medical Products | BSY | ||
| Z-1095-03 | Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus... | Zeus Scientific LLC | LFZ | ||
| Z-1047-03 | AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM... | Abbott Medical | LOK | ||
| Z-0935-04 | Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline... | Siemens Healthcare Diagnostics Inc. | KLT | ||
| Z-1074-03 | PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double... | Paceline, Inc. | : | ||
| Z-1007-03 | Misys Laboratory System, versions 5.2, 5.23 and 5.3 | CliniSys, Inc | JQP | ||
| Z-1136-03 | 75-1650 Drip Chambers .138rr; Abbott, Ashland, Ohio 44805; 800 drip chambers per case... | Abbott Medical | FPA | ||
| Z-1135-03 | 96-8369 Micro Drip Chambers, Convertible with Pierce Pin Assembly; Abbott, Ashland, Ohio... | Abbott Medical | FPA | ||
| Z-1134-03 | 96-8366 Drip Chambers, Convertible with Pierce Pin .138 Assembly; Abbott, Ashland, Ohio... | Abbott Medical | FPA | ||
| Z-1060-03 | Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E... | Medex Inc | CAJ | ||
| Z-0959-03 | Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories... | Abbott Medical | FPA |