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

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

59,544 records, page 609 of 1191
FDA device recalls, page 609 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0977-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)Xeridiem Medical DevicesPIF
Z-0976-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-0050-A16) The...Xeridiem Medical DevicesPIF
Z-0975-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The...Xeridiem Medical DevicesPIF
Z-0974-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The...Xeridiem Medical DevicesPIF
Z-0973-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The...Xeridiem Medical DevicesPIF
Z-0972-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) The...Xeridiem Medical DevicesPIF
Z-0971-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548900 (XMD P/N 70-0050-920) The...Xeridiem Medical DevicesPIF
Z-0970-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The...Xeridiem Medical DevicesPIF
Z-0969-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548580 (XMD P/N 70-0050-916) The...Xeridiem Medical DevicesPIF
Z-0968-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)Xeridiem Medical DevicesPIF
Z-0967-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548300 (XMD P/N 70-0050-912) The...Xeridiem Medical DevicesPIF
Z-0966-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549520 (XMD P/N 70-0050-824) The...Xeridiem Medical DevicesPIF
Z-0965-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549380 (XMD P/N 70-0050-822) The...Xeridiem Medical DevicesPIF
Z-0964-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-0050-820) The...Xeridiem Medical DevicesPIF
Z-0963-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) The...Xeridiem Medical DevicesPIF
Z-0962-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: MM00548410 (XMD P/N 70-0050-814) The...Xeridiem Medical DevicesPIF
Z-0961-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) The...Xeridiem Medical DevicesPIF
Z-0960-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The...Xeridiem Medical DevicesPIF
Z-0959-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The...Xeridiem Medical DevicesPIF
Z-0958-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The...Xeridiem Medical DevicesPIF
Z-0855-2016Class IIStryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.Howmedica Osteonics CorpJDR
Z-1095-2016Class IIBattery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max...Pro-Dex IncMOQ
Z-1094-2016Class IIBattery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin...Pro-Dex IncMOQ
Z-0957-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The...Xeridiem Medical DevicesPIF
Z-0956-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548560 (XMD P/N 70-0050-716) The...Xeridiem Medical DevicesPIF
Z-0955-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548400 (XMD P/N 70-0050-714) The...Xeridiem Medical DevicesPIF
Z-0954-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) The...Xeridiem Medical DevicesPIF
Z-0953-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-0050-624) The...Xeridiem Medical DevicesPIF
Z-0952-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The...Xeridiem Medical DevicesPIF
Z-0951-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-0050-620) The...Xeridiem Medical DevicesPIF
Z-0950-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-0050-618) The...Xeridiem Medical DevicesPIF
Z-0949-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548550 (XMD P/N 70-0050-616) The...Xeridiem Medical DevicesPIF
Z-0948-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548390 (XMD P/N 70-0050-614) The...Xeridiem Medical DevicesPIF
Z-0947-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-0050-612) The...Xeridiem Medical DevicesPIF
Z-0946-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The...Xeridiem Medical DevicesPIF
Z-0945-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) The...Xeridiem Medical DevicesPIF
Z-0944-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-0050-520) The...Xeridiem Medical DevicesPIF
Z-0943-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548700 (XMD P/N 70-0050-518) The...Xeridiem Medical DevicesPIF
Z-0942-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The...Xeridiem Medical DevicesPIF
Z-0941-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) The...Xeridiem Medical DevicesPIF
Z-0940-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) The...Xeridiem Medical DevicesPIF
Z-0939-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549480 (XMD P/N 70-0050-424) The...Xeridiem Medical DevicesPIF
Z-0938-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) The...Xeridiem Medical DevicesPIF
Z-0937-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548850 (XMD P/N 70-0050-420) The...Xeridiem Medical DevicesPIF
Z-0936-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The...Xeridiem Medical DevicesPIF
Z-0935-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The...Xeridiem Medical DevicesPIF
Z-0934-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The...Xeridiem Medical DevicesPIF
Z-0933-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The...Xeridiem Medical DevicesPIF
Z-0932-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The...Xeridiem Medical DevicesPIF
Z-0931-2016Class IIEndoVive 3s Low Profile Balloon Kits Part Number: M00549330 (XMD P/N 70-0050-322) The...Xeridiem Medical DevicesPIF