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-0324-2010 | 28CM ALTA LR STANDARD KIT Model: AL23NH28 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0323-2010 | 24CM ALTA LR STANDARD KIT Model: AL19NH24 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0322-2010 | 40CM ALTA LR STANDARD KIT Model: AL35SH40 ALTA CATHETER WITH SIDE HOLES 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0321-2010 | 36CM ALTA LR STANDARD KIT Model: AL31SH36 ALTA CATHETER WITH SIDE HOLES 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0320-2010 | 32CM ALTA LR STANDARD KIT Model: AL27SH32 ALTA CATHETER WITH SIDE HOLES 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0319-2010 | 28CM ALTA LR STANDARD KIT High Flow Recirculation Model: AL23SH28 ALTA CATHETER WITH... | Spire Biomedical, Inc. | MSD | ||
| Z-0318-2010 | 24CM ALTA LR STANDARD KIT High Flow Recirculation Catheter Model: AL19SH24 ALTA... | Spire Biomedical, Inc. | MSD | ||
| Z-0317-2010 | 32CM DECATHLON GOLD FUNNEL TIP STD KIT Model: DFC27SH32 15.5 Fr polyurethane twin... | Spire Biomedical, Inc. | MSD | ||
| Z-0316-2010 | 28CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC23SH28 and DFC23SH28-K DECATHLON... | Spire Biomedical, Inc. | MSD | ||
| Z-0315-2010 | 24CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC19SH24 and DFC19SH24-K DECATHLON... | Spire Biomedical, Inc. | MSD | ||
| Z-0314-2010 | 55CM DECATHLON GOLD STD KIT Models: DEC50SH55 and DEC50SH55-K DECATHLON GOLD 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0313-2010 | 40CM DECATHLON GOLD STD KIT Models: DEC35SH40 and DEC35SH40-K DECATHLON GOLD 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0312-2010 | 36CM DECATHLON GOLD STD KIT Models: DEC31SH36 and DEC31SH36-K DECATHLON GOLD 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0311-2010 | 32CM DECATHLON GOLD STD KIT Models: DEC27SH32 and DEC27SH32-K DECATHLON GOLD 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0310-2010 | 28CM DECATHLON GOLD STD KIT Models: DEC23SH28 and DEC23SH28-K | Spire Biomedical, Inc. | MSD | ||
| Z-0309-2010 | 24CM DECATHLON GOLD STD KIT Models: DEC19SH24 and DEC19SH24-K DECATHLON GOLD 15.5... | Spire Biomedical, Inc. | MSD | ||
| Z-0308-2010 | 32CM DECATHLON EXCHANGE KIT Model: DX27SH32-XP DECATHLON MINI KIT 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0307-2010 | 28CM DECATHLON EXCHANGE KIT Model: DX23SH28-XP DECATHLON MINI KIT 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0306-2010 | 24CM DECATHLON EXCHANGE KIT Model: DX19SH24-XP DECATHLON MINI KIT 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0305-2010 | 32CM DECATHLON MINI KIT Model: DM27SH32 DECATHLON MINI KIT 15.5 Fr polyurethane twin... | Spire Biomedical, Inc. | MSD | ||
| Z-0304-2010 | 28CM DECATHLON MINI KIT Model: DM23SH28 DECATHLON MINI KIT 15.5 Fr polyurethane twin... | Spire Biomedical, Inc. | MSD | ||
| Z-0303-2010 | 24CM DECATHLON MINI KIT Model: DM19SH24 DECATHLON MINI KIT 15.5 Fr polyurethane twin... | Spire Biomedical, Inc. | MSD | ||
| Z-0302-2010 | 32CM DECATHLON FUNNEL TIP CATHETER Model: DF27SH32-100 DECATHLON FUNNEL TIP... | Spire Biomedical, Inc. | MSD | ||
| Z-0301-2010 | 28CM DECATHLON FUNNEL TIP CATHETER Model: DF23SH28-100 DECATHLON FUNNEL TIP... | Spire Biomedical, Inc. | MSD | ||
| Z-0300-2010 | 24CM DECATHLON FUNNEL TIP CATHETER Model: DF19SH24-100 DECATHLON FUNNEL TIP... | Spire Biomedical, Inc. | MSD | ||
| Z-0299-2010 | 55CM DECATHLON FUNNEL TIP STD KIT Model: DF50SH55 DECATHLON FUNNEL TIP 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0298-2010 | 40CM DECATHLON FUNNEL TIP STD KIT Model: DF35SH40 DECATHLON FUNNEL TIP 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0297-2010 | 36CM DECATHLON FUNNEL TIP STD KIT Model: DF31SH36 DECATHLON FUNNEL TIP 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0296-2010 | 32CM DECATHLON FUNNEL TIP STD KIT Model: DF27SH32 DECATHLON FUNNEL TIP 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0295-2010 | 28CM DECATHLON FUNNEL TIP STD KIT Model: DF23SH28 DECATHLON FUNNEL TIP 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0294-2010 | 24CM DECATHLON FUNNEL TIP STD KIT Model: DF19SH24 DECATHLON FUNNEL TIP 15.5 Fr... | Spire Biomedical, Inc. | MSD | ||
| Z-0293-2010 | 55CM DECATHLON STD KIT Models: DE50SH55 and DE50SH55-K 15.5 Fr Polyurethane twin... | Spire Biomedical, Inc. | MSD | ||
| Z-0292-2010 | 40CM DECATHLON STD KIT Models: DE35SH40 and DE35SH40-K 15.5 Fr Polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0291-2010 | 36CM DECATHLON STD KIT Models: DE31SH36 and DE31SH36-K 15.5 Fr Polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0290-2010 | 32CM DECATHLON STD KIT Models: DE27SH32 and DE27SH32-K 15.5 Fr Polyurethane twin... | Spire Biomedical, Inc. | MSD | ||
| Z-0289-2010 | 28CM DECATHLON STD KIT Models: DE23SH28 and DE23SH28-K 15.5 Fr Polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0288-2010 | 24CM DECATHLON STD KIT Models: DE19SH24 and DE19SH24-K 15.5 Fr Polyurethane twin lumen... | Spire Biomedical, Inc. | MSD | ||
| Z-0337-2010 | Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for... | Boston Scientific Corporation | KOD | ||
| Z-0336-2010 | Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for... | Boston Scientific Corporation | DQO | ||
| Z-1039-2010 | Dimension Vista V-LYTE Fluids: Diluent catalog number K835 | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1038-2010 | Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825 | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1037-2010 | Dimension Vista V-LYTE Fluids: Standard A catalog number K820 | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0482-2010 | TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The... | Jeneric/Pentron, Inc. | EBG | ||
| Z-0480-2010 | Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component... | Maquet Cardiovascular Us Sales, LLC | FWZ | ||
| Z-0541-2010 | GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound... | GE Healthcare | IYO | ||
| Z-1066-2010 | IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 | Siemens Healthcare Diagnostics Inc. | LFX | ||
| Z-1033-2010 | IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 | Siemens Healthcare Diagnostics Inc. | LFX | ||
| Z-0120-2010 | Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis... | Merit Medical Systems, Inc. | DYB | ||
| Z-0418-2010 | IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version... | Philips North America LLC | DXJ | ||
| Z-1639-2010 | Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site... | Vygon Mfg | FPA |