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

59,460 records, page 1143 of 1190
FDA device recalls, page 1143 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1350-04Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, malleable stylet...Terumo Cardiovascular Systems CorporationDWF
Z-1349-04Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, steerable stylet...Terumo Cardiovascular Systems CorporationDWF
Z-1348-04Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 17 Fr, malleable stylet...Terumo Cardiovascular Systems CorporationDWF
Z-1347-04Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 17 Fr, malleable stylet...Terumo Cardiovascular Systems CorporationDWF
Z-1346-04Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 17 Fr, steerable stylet...Terumo Cardiovascular Systems CorporationDWF
Z-1436-04AxSYM Total B-hCG Reagent PackAbbott Diagnostic International, Ltd.JHI
Z-1368-04Amplicor [3] AV-HRP, Avidin-HRP Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR NG...Roche Molecular Systems IncLSL
Z-1367-04Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR...Roche Molecular Systems IncMWA
Z-1366-04Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR M...Roche Molecular Systems Inc
Z-1365-04Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR IC...Roche Molecular Systems Inc
Z-1364-04Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AmpliCap...Roche Molecular Systems IncMZP
Z-1363-04Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor...Roche Molecular Systems Inc
Z-1362-04Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor...Roche Molecular Systems IncMZP
Z-1361-04Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor...Roche Molecular Systems IncLSL
Z-1360-04Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor...Roche Molecular Systems IncMKZ
Z-0013-05Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.Zimmer GmbHHTY
Z-1345-04Sarns brand Retrograde Cardioplegia Cannulae, manual -inflate, 17 Fr, guidewire stylet...Terumo Cardiovascular Systems CorporationDWF
Z-1440-04Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampulB Braun Medical IncBSP
Z-1439-04Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampulB Braun Medical IncBSP
Z-1311-06TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens...Tekia IncHQL
Z-1326-04BBL Columbia C.N.A. Agar w/5% Sheep Blood - Catalog Number 297831.Becton Dickinson & CoJSO
Z-1325-04BBL Brain Heart Infusion Agar CC w/Sheep Blood - Catalog Number 296178.Becton Dickinson & CoJSO
Z-1324-04BBL Columbia C.N.A. Agar w/5% Sheep Blood/Levine EMB - Catalog Number 295618.Becton Dickinson & CoJSO
Z-1323-04BBL TSA II w/5% Sheep Blood, Spacesaver - Catalog Number 292537.Becton Dickinson & CoJSO
Z-1322-04BBL Brain Heart Infusion Agar w/10% Sheep Blood - Catalog Number 297655.Becton Dickinson & CoJSO
Z-1321-04Sheep Blood, Defibrinated - Catalog Number 212390, Unit 60 ml.Becton Dickinson & CoJSO
Z-1320-04Sheep Blood, Defibrinated - Catalog Number 211945, Unit 15 ml.Becton Dickinson & CoJSO
Z-1319-04Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml.Becton Dickinson & CoJSO
Z-1318-04Sheep Blood, Defibrinated - Catalog Number 212389, Unit 30 ml.Becton Dickinson & CoJSO
Z-1317-04Sheep Blood, Defibrinated - Catalog Number 212391, Unit 250 ml.Becton Dickinson & CoJSO
Z-1299-044795-20 Saddle Block 25G Quincke w/ drugsAbbott MedicalCAZ
Z-1298-04A3121-25 Spinal (Sdd) W/drugsAbbott MedicalCAZ
Z-1297-04A3077-25 Spinal (Sdd) W/drugsAbbott MedicalCAZ
Z-1296-04A3075-25 Spinal (Sdd) W/drugsAbbott MedicalCAZ
Z-1295-04A3065-25 Spinal Tray (Sdd) W/drugsAbbott MedicalCAZ
Z-1294-04A3015-25 Spinal (Sdd) W/drugsAbbott MedicalCAZ
Z-1293-04A2971-25 Spinal (Shb) W/drugsAbbott MedicalCAZ
Z-1292-04A2957 Spinal (Sdd) W/drugs K516566Abbott MedicalCAZ
Z-1291-04A2837 Spinal(sdd)w/drugsAbbott MedicalCAZ
Z-1304-04Achillon minimally invasive Achilles tendon suture systemWright Medical Technology IncMCZ
Z-1290-04A2832-25 Spinal Tray (Sdd) W/ DrugsAbbott MedicalCAZ
Z-1289-04A2814 Spinal (Sdd)w/drugsAbbott MedicalCAZ
Z-1288-04A2705-26 Spinal (SHB) w/ DrugsAbbott MedicalCAZ
Z-1287-04A2675-25 Spinal(shb)w/drugsAbbott MedicalCAZ
Z-1286-04A2654-24 Spinal (Fl) W/drugsAbbott MedicalCAZ
Z-1285-04A2624-22/25 Spinal (Sdd) W/drugsAbbott MedicalCAZ
Z-1284-04A2613 Spinal(fl)w/drugsAbbott MedicalCAZ
Z-1283-04A2527-27 Spinal (Shb) W/drugsAbbott MedicalCAZ
Z-1282-04A2526-24 Spinal (Shb) W/drugsAbbott MedicalCAZ
Z-1316-04Sheep Blood, Defibrinated - Catalog Number 211946, Unit 100 ml.Becton Dickinson & CoJSO