510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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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 462 of 1191
FDA device recalls, page 462 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2405-2018Class IIFemoral Nail, RIGHT T2 GTN 9x320 mm, Product Number 18510932SStryker Corp.HSB
Z-2404-2018Class IIFemoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430SStryker Corp.HSB
Z-2403-2018Class IIFemoral Nail, LEFT T2 GTN 12x360 mm, Product Number 18501236SStryker Corp.HSB
Z-2402-2018Class IIFemoral Nail, LEFT T2 GTN 10x360 mm, Product Number 18501036SStryker Corp.HSB
Z-2401-2018Class IIFemoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238SStryker Corp.HSB
Z-2400-2018Class IIFemoral Nail, A/R, R1500 T2 Femur 12x360 mm, Product Number 18281236SStryker Corp.HSB
Z-2399-2018Class IIFemoral Nail, A/R, R1500 T2 Femur 12x300 mm, Product Number 18281230SStryker Corp.HSB
Z-2398-2018Class IIFemoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032SStryker Corp.HSB
Z-2397-2018Class IIFemoral Nail, A/R T2 Femur 15x240 mm, Product Number 18251524SStryker Corp.HSB
Z-2396-2018Class IIFemoral Nail, A/R T2 Femur 12x360 mm, Product Number 18251236SStryker Corp.HSB
Z-2395-2018Class IIFemoral Nail, A/R T2 Femur 10x340 mm, Product Number 18251034SStryker Corp.HSB
Z-2394-2018Class IIFemoral Nail, A/R T2 Femur 10x320 mm, Product Number 18251032SStryker Corp.HSB
Z-2393-2018Class IITibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231SStryker Corp.HSB
Z-2390-2018Class IIElecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product...Roche Diagnostics GmbHMRG
Z-2389-2018Class IIElecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product...Roche Diagnostics GmbHMRG
Z-1954-2018Class IICarina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment...Draeger, Inc.CBK
Z-2286-2018Class IIABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for...Horiba Instruments IncorporatedPFT
Z-1866-2018Class IIBOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA...Medtronic, Inc.GDW
Z-1865-2018Class IIBOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal and Endo GIA...Medtronic, Inc.GDW
Z-1863-2018Class IIBOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and Endo GIA...Medtronic, Inc.GDW
Z-1862-2018Class IIBOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA universal and Endo...Medtronic, Inc.GDW
Z-1859-2018Class II(1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE...Medtronic, Inc.GDW
Z-1858-2018Class IISLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo...Medtronic, Inc.GDW
Z-1855-2018Class II(1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX...Medtronic, Inc.GDW
Z-1854-2018Class IIBOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo...Medtronic, Inc.GDW
Z-1852-2018Class IIBOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and Endo GIA...Medtronic, Inc.GDW
Z-1850-2018Class IIMGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA universal XL...Medtronic, Inc.GDW
Z-1849-2018Class II(1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403...Medtronic, Inc.GDW
Z-1848-2018Class IIBOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA universal and Endo...Medtronic, Inc.GDW
Z-1847-2018Class II(1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO...Medtronic, Inc.GDW
Z-1844-2018Class IIBOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and...Medtronic, Inc.GDW
Z-1843-2018Class II(1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item...Medtronic, Inc.GDW
Z-1842-2018Class II(1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT...Medtronic, Inc.GDW
Z-1840-2018Class II(1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX)...Medtronic, Inc.GDW
Z-1839-2018Class IIBOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and...Medtronic, Inc.GDW
Z-1838-2018Class II(1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2)...Medtronic, Inc.GDW
Z-1837-2018Class IIKIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA...Medtronic, Inc.GDW
Z-1834-2018Class IIBOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA...Medtronic, Inc.GDW
Z-1833-2018Class IIBOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal...Medtronic, Inc.GDW
Z-1832-2018Class IIBOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal...Medtronic, Inc.GDW
Z-1831-2018Class IIKIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) Product...Medtronic, Inc.GDW
Z-1830-2018Class II(1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO...Medtronic, Inc.GDW
Z-1829-2018Class II(1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX...Medtronic, Inc.GDW
Z-1828-2018Class IIBOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS...Medtronic, Inc.GDW
Z-1826-2018Class II(1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX...Medtronic, Inc.GDW
Z-1825-2018Class IIBOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA universal and...Medtronic, Inc.GDW
Z-1824-2018Class IICovidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA"...Medtronic, Inc.GDW
Z-1823-2018Class IIEndo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology(...Medtronic, Inc.GDW
Z-1822-2018Class IIEndo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology(...Medtronic, Inc.GDW
Z-1821-2018Class IIEndo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology(...Medtronic, Inc.GDW