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-1105-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1104-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 1.5 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1103-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1102-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 1.5 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1101-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 2.0 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1100-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1099-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1098-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1097-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1096-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon... | Boston Scientific Corporation | GBR | ||
| Z-1059-03 | Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns... | Cook Incorporated | |||
| Z-1058-03 | Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns... | Cook Incorporated | |||
| Z-1057-03 | Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns... | Cook Incorporated | |||
| Z-1056-03 | Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 180-300 microns... | Cook Incorporated | |||
| Z-1055-03 | Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 90-180 microns... | Cook Incorporated | |||
| Z-1054-03 | Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1... | Cook Incorporated | |||
| Z-0360-2008 | Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model... | Plus Orthopedics | KTT | ||
| Z-0557-04 | The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST... | Scion Cardio-Vascular, Inc. | FGO | ||
| Z-1049-03 | SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33). | Power Medical Interventions, Inc. | GAG | ||
| Z-1048-03 | SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29) | Power Medical Interventions, Inc. | GAG | ||
| Z-1024-03 | Catalog SBA35GSMOG, Sterile General Surgery Pack, Mfg date 5/21/03, order 101467; | Medtronic, Inc. | LRO | ||
| Z-1023-03 | Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438; | Medtronic, Inc. | LRO | ||
| Z-1022-03 | Catalog SBA11GLMMD, Sterile General Local Tray, Mfg date 5/20/03, exp date 1/01/05, order... | Medtronic, Inc. | LRO | ||
| Z-1021-03 | Catalog SBA21MAHVJ, Sterile Major Abdominal Pack, Mfg date 5/22/03, Exp date 1/01/05... | Medtronic, Inc. | LRO | ||
| Z-1046-03 | Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8878... | Henry Schein, Inc. | LYY | ||
| Z-1043-03 | ProVision Disposable Hood; product 5431-50-000 | Depuy Orthopaedics Inc. | FYA | ||
| Z-1042-03 | ProVision Barrier Universal Hood/Gown; product 5431-33-000 | Depuy Orthopaedics Inc. | FYA | ||
| Z-1041-03 | ProVision Hytrel Universal Hood/Gown; product 5431-31-000 | Depuy Orthopaedics Inc. | FYA | ||
| Z-1040-03 | ProVision Hytrel Elastomer Hood; product 5431-05-000. | Depuy Orthopaedics Inc. | FYA | ||
| Z-1045-03 | Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8843... | Henry Schein, Inc. | LYY | ||
| Z-1020-03 | Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park... | Medtronic, Inc. | LRO | ||
| Z-1139-03 | Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences... | Revvity Health Sciences, Inc. | JLJ | ||
| Z-1125-03 | Easy Access Software releases 1.1, 5.2, 6.2 & 7.2 | Philips North America LLC | LLZ | ||
| Z-1019-03 | Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number... | Boston Scientific Corporation | |||
| Z-0983-03 | CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium... | Numed Inc | MAF | ||
| Z-1044-03 | MagNA Pure LC Instrument; Catalog number 2236931. | Roche Diagnostics GmbH | JQP | ||
| Z-1076-03 | Blood Agar Plates, 5%, Lot 3155A. | Hardy Diagnostics | |||
| Z-0978-03 | SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric... | CooperVision, Inc. | LPL | ||
| Z-1441-04 | Anestar Anesthesia Delivery System | Datascope Corp. | BSZ | ||
| Z-1154-04 | Power Processor Aliquot Tube Labels Part 800255 | Siemens Healthcare Diagnostics Inc. | |||
| Z-1093-03 | Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation. | CliniSys, Inc | JQP | ||
| Z-1052-03 | EM2M NC AEM Monitor, (NON-COM) | Encision, Inc. | GEI | ||
| Z-1051-03 | EM2+A NC AEM Monotor (NON-COM) | Encision, Inc. | GEI | ||
| Z-1050-03 | EM2 NC AEM Monitor (NON-COM) | Encision, Inc. | GEI | ||
| Z-1017-03 | Pulsar Max II Multiprogrammable Pacemaker, Model 1280 | Boston Scientific Corporation | DXY | ||
| Z-1034-03 | Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906 | Boston Scientific Corporation | |||
| Z-1033-03 | Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm Catalog no. 372403 | Boston Scientific Corporation | |||
| Z-1016-03 | Discovery II Multiprogrammable Pacemaker, Model 1286 | Boston Scientific Corporation | DXY | ||
| Z-1015-03 | Discovery II Multiprogrammable Pacemaker, Model 1284 | Boston Scientific Corporation | DXY | ||
| Z-1014-03 | Discovery II Multiprogrammable Pacemaker, Model 1283 | Boston Scientific Corporation | DXY |