510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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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

59,528 records, page 712 of 1191
FDA device recalls, page 712 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1447-2014Class IIK-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended...Breg IncIQI
Z-1446-2014Class IIEconomy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The...Breg IncIQI
Z-1445-2014Class IIAlcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal...Alcon Lensx, Inc.OOE
Z-2544-2014Class IIMedtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512...Medtronic, Inc.OYC
Z-1320-2014Class IIMerit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.Merit Medical Systems, Inc.FMF
Z-1319-2014Class IIPressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used...Merit Medical Systems, Inc.OBI
Z-1449-2014Class IICobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical...Roche Diagnostics GmbHJJE
Z-1335-2014Class II5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number...Intuitive Surgical, Inc.NAY
Z-1334-2014Class II5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number...Intuitive Surgical, Inc.NAY
Z-1333-2014Class II5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number...Intuitive Surgical, Inc.NAY
Z-1332-2014Class II5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number...Intuitive Surgical, Inc.NAY
Z-1678-2014Class IIIntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number...Philips North America LLCKPS
Z-1535-2014Class IIDekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic...Teleflex MedicalGAM
Z-1534-2014Class IICAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm)...Teleflex MedicalNEW
Z-1509-2014Class IIMonodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48Teleflex MedicalNEW
Z-1497-2014Class IIMonofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2...Teleflex MedicalGAQ
Z-1561-2014Class IIDeknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture...Teleflex MedicalGAP
Z-1560-2014Class IIDeknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel...Teleflex MedicalGAQ
Z-1328-2014Class II5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No...Teleflex MedicalGCJ
Z-1327-2014Class II5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An...Teleflex MedicalGCJ
Z-1326-2014Class II5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista...Teleflex MedicalGCJ
Z-1325-2014Class II5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R...Teleflex MedicalGCJ
Z-1324-2014Class II10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog...Teleflex MedicalGCJ
Z-1323-2014Class IIWeck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck...Teleflex MedicalGCJ
Z-1296-2014Class IISutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable...Teleflex MedicalGAT
Z-1295-2014Class IISutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only...Teleflex MedicalGAT
Z-1294-2014Class IISutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage...Teleflex MedicalGAT
Z-1293-2014Class IISutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product...Teleflex MedicalGAT
Z-1292-2014Class IISutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage...Teleflex MedicalGAT
Z-1291-2014Class IISuture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product...Teleflex MedicalGAT
Z-1559-2014Class IIBard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC...Teleflex MedicalGAT
Z-1558-2014Class IIFixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic...Teleflex MedicalGAM
Z-1557-2014Class IITeleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile...Teleflex MedicalGAQ
Z-1556-2014Class IITeleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile...Teleflex MedicalGAT
Z-1555-2014Class IINonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize...Teleflex MedicalGAR
Z-1290-2014Class II5/10/12 Weck Vista" Universal Balloon Open Access Port Long Length (100mm), Product...Teleflex MedicalGCJ
Z-1289-2014Class II5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm), Product...Teleflex MedicalGCJ
Z-1288-2014Class II5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), Product...Teleflex MedicalGCJ
Z-1287-2014Class II5/10 Weck Vista" Universal Balloon Open Access Port - Long Length (100mm), Product...Teleflex MedicalGCJ
Z-1286-2014Class II5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product...Teleflex MedicalGCJ
Z-1285-2014Class II5/10/12MM X 100MM Weck Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope...Teleflex MedicalGCJ
Z-1284-2014Class II5/10/12 mm Weck Vista" Universal Cannula, Product Usage: An endoscope and accessories...Teleflex MedicalGCJ
Z-1283-2014Class II5/10/12 mm Weck Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An...Teleflex MedicalGCJ
Z-1282-2014Class II12mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and...Teleflex MedicalGCJ
Z-1281-2014Class IIWeck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An...Teleflex MedicalGCJ
Z-1280-2014Class IIWeck Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An...Teleflex MedicalGCJ
Z-1279-2014Class II5/10 mm Weck, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope...Teleflex MedicalGCJ
Z-1278-2014Class II5/10 mm Weck, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An...Teleflex MedicalGCJ
Z-1277-2014Class II10mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and...Teleflex MedicalGCJ
Z-1276-2014Class IIWeck Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An...Teleflex MedicalGCJ