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-0463-05 | Custom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part... | Abbott Medical | |||
| Z-1343-04 | Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts... | Spinal Concepts, Inc. | MQP | ||
| Z-1095-04 | Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0905-04 | Coulter LH750 Hematology Analyzer. Part Number 6605632. | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0994-04 | T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035. | Howmedica Osteonics Corp | LXH | ||
| Z-0360-04 | Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials... | Coherent, Inc. | L--22 | ||
| Z-0853-04 | GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number... | GE Healthcare | EAM | ||
| Z-0852-04 | GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number... | GE Healthcare | EAM | ||
| Z-0851-04 | GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number... | GE Healthcare | EAM | ||
| Z-0850-04 | GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number... | GE Healthcare | EAM | ||
| Z-0830-04 | ABG Replacement Pump Assembly Catalog Number: 37092 | Nova Biomedical Corporation | CHL | ||
| Z-0829-04 | Stat Profile Critical Care Xpress CCX+ (R) Anaylzer Catalog NUmber: 37555 R= Refurbished | Nova Biomedical Corporation | CHL | ||
| Z-0828-04 | Stat Profile Critical Care Xpress CCX (R) Analyzer Catalog Number: 37562 R= Refurbished | Nova Biomedical Corporation | CHL | ||
| Z-0827-04 | Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413 | Nova Biomedical Corporation | CHL | ||
| Z-0826-04 | Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942 | Nova Biomedical Corporation | CHL | ||
| Z-0907-04 | Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40 | Advanced Medical Optics, Inc. | HQC | ||
| Z-0878-04 | Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with... | Abbott Medical | LJT | ||
| Z-0877-04 | Port-A-Cath II Dual-lumen Low Profile Polysulfone/Titanium Venous Access System, with... | Abbott Medical | LJT | ||
| Z-0876-04 | Port-A-Cath II Fluoro-Free Low Profile Venous Access System, with PolyFlow Polyurethane... | Abbott Medical | LJT | ||
| Z-0875-04 | Port-A-Cath P.A.S. Port T2 Titanium Venous Access System, with PolyFlow Polyurethane... | Abbott Medical | LJT | ||
| Z-0874-04 | ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter... | Abbott Medical | LJT | ||
| Z-0873-04 | ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter... | Abbott Medical | LJT | ||
| Z-0872-04 | ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter... | Abbott Medical | LJT | ||
| Z-0871-04 | ProPort Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x... | Abbott Medical | LJT | ||
| Z-0870-04 | Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with... | Abbott Medical | LJT | ||
| Z-0869-04 | Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow... | Abbott Medical | LJT | ||
| Z-0868-04 | Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with... | Abbott Medical | LJT | ||
| Z-0867-04 | Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow... | Abbott Medical | LJT | ||
| Z-0866-04 | Port-A-Cath II Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane... | Abbott Medical | LJT | ||
| Z-0865-04 | Port-A-Cath II Polysulfone/Titanium Venous Access System, with Silicone Catheter, 2.8mm... | Abbott Medical | LJT | ||
| Z-0864-04 | Port-A-Cath Low Profile Titanium Venous Access System, with PolyFlow Polyurethane... | Abbott Medical | LJT | ||
| Z-0863-04 | Port-A-Cath Low Profile Titanium Venous Access System, with Silicone Catheter, 2.8mm... | Abbott Medical | LJT | ||
| Z-0862-04 | Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm... | Abbott Medical | LJT | ||
| Z-0861-04 | Port-A-Cath Titanium Venous Access System, with Silicone Catheter, 2.8mm O.D. x 1.0mm... | Abbott Medical | LJT | ||
| Z-0860-04 | 8.5 Fr Introducer Set, REF 21-2370-24 | Abbott Medical | DYB | ||
| Z-0859-04 | 9 Fr Introducer Set, REF 21-2340-24 | Abbott Medical | DYB | ||
| Z-0858-04 | 6 Fr Introducer Set, REF 21-2320-24 | Abbott Medical | DYB | ||
| Z-0857-04 | Port-A-Cath II Epidural Low Profile Polysulfone/Titanium Access System, with PolyFlow... | Abbott Medical | MDV | ||
| Z-0904-04 | UniCel Dxl 800 Access Immunoassay System, P/N 973100. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0940-04 | K-Assay Lp(a) Control | Kamiya Biomedical Company, LLC | DFC | ||
| Z-0847-04 | Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog... | Boston Scientific Corporation | |||
| Z-0834-04 | HENRY SCHEIN(R) 100-8008 Explorer-Double End #5. Barcode *+H658100800808*. Made in... | HU-Friedy Mfg. Co. LLC | EKB | ||
| Z-0833-04 | HENRY SCHEIN(R) 100-3620 Explorer-Single End #23 SE. Barcode *+H658100362003*. Made in... | HU-Friedy Mfg. Co. LLC | EKB | ||
| Z-0832-04 | HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For... | HU-Friedy Mfg. Co. LLC | EKB | ||
| Z-0856-04 | Port-A-Cath II Low Profile Epidural Implantable Access System, with PolyFlow Polyurethane... | Abbott Medical | LNY | ||
| Z-0895-04 | STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with... | Salter Labs | BTM | ||
| Z-0894-04 | STAT-Check Infant Disposable Manual Resuscitators, with 40 cmHO Pressure Limiting System... | Salter Labs | BTM | ||
| Z-0893-04 | A.C.E. STAT-Check CO Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex... | Salter Labs | BTM | ||
| Z-0892-04 | STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator... | Salter Labs | BTM | ||
| Z-0891-04 | STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator... | Salter Labs | BTM |