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-1447-2014 | Class II | K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended... | Breg Inc | IQI | |
| Z-1446-2014 | Class II | Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The... | Breg Inc | IQI | |
| Z-1445-2014 | Class II | Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal... | Alcon Lensx, Inc. | OOE | |
| Z-2544-2014 | Class II | Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512... | Medtronic, Inc. | OYC | |
| Z-1320-2014 | Class II | Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO. | Merit Medical Systems, Inc. | FMF | |
| Z-1319-2014 | Class II | Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used... | Merit Medical Systems, Inc. | OBI | |
| Z-1449-2014 | Class II | Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical... | Roche Diagnostics GmbH | JJE | |
| Z-1335-2014 | Class II | 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number... | Intuitive Surgical, Inc. | NAY | |
| Z-1334-2014 | Class II | 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number... | Intuitive Surgical, Inc. | NAY | |
| Z-1333-2014 | Class II | 5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number... | Intuitive Surgical, Inc. | NAY | |
| Z-1332-2014 | Class II | 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number... | Intuitive Surgical, Inc. | NAY | |
| Z-1678-2014 | Class II | IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number... | Philips North America LLC | KPS | |
| Z-1535-2014 | Class II | Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic... | Teleflex Medical | GAM | |
| Z-1534-2014 | Class II | CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm)... | Teleflex Medical | NEW | |
| Z-1509-2014 | Class II | Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 | Teleflex Medical | NEW | |
| Z-1497-2014 | Class II | Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2... | Teleflex Medical | GAQ | |
| Z-1561-2014 | Class II | Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture... | Teleflex Medical | GAP | |
| Z-1560-2014 | Class II | Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel... | Teleflex Medical | GAQ | |
| Z-1328-2014 | Class II | 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No... | Teleflex Medical | GCJ | |
| Z-1327-2014 | Class II | 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An... | Teleflex Medical | GCJ | |
| Z-1326-2014 | Class II | 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista... | Teleflex Medical | GCJ | |
| Z-1325-2014 | Class II | 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R... | Teleflex Medical | GCJ | |
| Z-1324-2014 | Class II | 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog... | Teleflex Medical | GCJ | |
| Z-1323-2014 | Class II | Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck... | Teleflex Medical | GCJ | |
| Z-1296-2014 | Class II | Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable... | Teleflex Medical | GAT | |
| Z-1295-2014 | Class II | Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only... | Teleflex Medical | GAT | |
| Z-1294-2014 | Class II | Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage... | Teleflex Medical | GAT | |
| Z-1293-2014 | Class II | Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product... | Teleflex Medical | GAT | |
| Z-1292-2014 | Class II | Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage... | Teleflex Medical | GAT | |
| Z-1291-2014 | Class II | Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product... | Teleflex Medical | GAT | |
| Z-1559-2014 | Class II | Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC... | Teleflex Medical | GAT | |
| Z-1558-2014 | Class II | Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic... | Teleflex Medical | GAM | |
| Z-1557-2014 | Class II | Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile... | Teleflex Medical | GAQ | |
| Z-1556-2014 | Class II | Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile... | Teleflex Medical | GAT | |
| Z-1555-2014 | Class II | Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize... | Teleflex Medical | GAR | |
| Z-1290-2014 | Class II | 5/10/12 Weck Vista" Universal Balloon Open Access Port Long Length (100mm), Product... | Teleflex Medical | GCJ | |
| Z-1289-2014 | Class II | 5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm), Product... | Teleflex Medical | GCJ | |
| Z-1288-2014 | Class II | 5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), Product... | Teleflex Medical | GCJ | |
| Z-1287-2014 | Class II | 5/10 Weck Vista" Universal Balloon Open Access Port - Long Length (100mm), Product... | Teleflex Medical | GCJ | |
| Z-1286-2014 | Class II | 5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product... | Teleflex Medical | GCJ | |
| Z-1285-2014 | Class II | 5/10/12MM X 100MM Weck Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope... | Teleflex Medical | GCJ | |
| Z-1284-2014 | Class II | 5/10/12 mm Weck Vista" Universal Cannula, Product Usage: An endoscope and accessories... | Teleflex Medical | GCJ | |
| Z-1283-2014 | Class II | 5/10/12 mm Weck Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An... | Teleflex Medical | GCJ | |
| Z-1282-2014 | Class II | 12mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and... | Teleflex Medical | GCJ | |
| Z-1281-2014 | Class II | Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An... | Teleflex Medical | GCJ | |
| Z-1280-2014 | Class II | Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An... | Teleflex Medical | GCJ | |
| Z-1279-2014 | Class II | 5/10 mm Weck, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope... | Teleflex Medical | GCJ | |
| Z-1278-2014 | Class II | 5/10 mm Weck, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An... | Teleflex Medical | GCJ | |
| Z-1277-2014 | Class II | 10mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and... | Teleflex Medical | GCJ | |
| Z-1276-2014 | Class II | Weck Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An... | Teleflex Medical | GCJ |
