510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,486 records, page 862 of 1190
FDA device recalls, page 862 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2425-2012Class IIIULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark...Kimberly-Clark CorporationKKX
Z-3021-2011CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002...CIVCO Medical Instruments Co., Inc.IXQ
Z-3020-2011CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm...CIVCO Medical Instruments Co., Inc.IXQ
Z-3019-2011CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa...CIVCO Medical Instruments Co., Inc.IXQ
Z-1260-2011Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended...Ethicon, IncGDW
Z-2213-2011COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic...Siemens Healthcare Diagnostics Inc.GGK
Z-1552-2011SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8". Philips Medical...Philips North America LLCKPS
Z-1551-2011SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8"...Philips North America LLCKPS
Z-1550-2011Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8 Philips Medical Systems An imaging...Philips North America LLCJAK
Z-1549-2011Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8; Philips Medical Systems An...Philips North America LLCJAK
Z-1459-2011COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVDRoche Molecular Systems IncMKT
Z-1366-2011ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished)...ConMed CorporationGEI
Z-1729-2011Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro...Siemens Healthcare Diagnostics Inc.CGX
Z-1365-2011ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed...ConMed CorporationGEI
Z-1364-2011ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 V, ConMed...ConMed CorporationGEI
Z-1363-2011ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V, ConMed...ConMed CorporationGEI
Z-1362-2011ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed...ConMed CorporationGEI
Z-1340-2011Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For...Aspen Surgical Products, Inc.HMR
Z-1339-2011Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF...Aspen Surgical Products, Inc.HMR
Z-1338-2011CYNACON OcuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic...Aspen Surgical Products, Inc.HMR
Z-1337-2011Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in...Aspen Surgical Products, Inc.HMR
Z-1336-2011Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile...Aspen Surgical Products, Inc.HMR
Z-1335-2011Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery.Aspen Surgical Products, Inc.HMR
Z-1387-2011Masimo Hemoglobin Pronto-7 with Rainbow 40 Technology for easy-to-use spot-check testing...Masimo CorporationDQA
Z-1547-2011Cylindrical Reamer Bullet Nose Straight Flutes 20.5 mm x 250 mm, REF 475829, Biomet...Zimmer GmbHHTO
Z-1732-2011Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute...Siemens Healthcare Diagnostics Inc.MMI
Z-0934-2011Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following...H & P Industries, Inc. dba Triad GroupKMJ
Z-1546-2011Cylindrical Bullet Nose Reamer 19.5 mm x 250 mm, REF 475827, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1545-2011Cylindrical Bullet Nose Reamer 19.0 mm x 250 mm, REF 475826, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1544-2011Cylindrical Bullet Nose Reamer 18.0 mm x 250 mm, REF 475824, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1543-2011Cylindrical Bullet Nose Reamer 17.5 mm x 250 mm, REF 475823, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1542-2011Cylindrical Bullet Nose Reamer 15.5 mm x 250 mm, REF 475819, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1541-2011Cylindrical Bullet Nose Reamer 15.0 mm x 250 mm, REF 475818, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1540-2011Cylindrical Bullet Nose Reamer 14.5 mm x 250 mm, REF 475817, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1539-2011Cylindrical Bullet Nose Reamer 14.0 mm x 250 mm, REF 475816, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1538-2011Cylindrical Bullet Nose Reamer 13.5 mm x 250 mm, REF 475815, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1537-2011Cylindrical Bullet Nose Reamer 13.0 mm x 250 mm, REF 475814, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1536-2011Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1535-2011Cylindrical Bullet Nose Reamer 12.0 mm x 250 mm, REF 475812, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1534-2011Cylindrical Bullet Nose Reamer 11.5 mm x 250 mm, REF 475811, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1533-2011Cylindrical Bullet Nose Reamer 11.0 mm x 250 mm, REF 475810, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1532-2011Cylindrical Bullet Nose Reamer 10.5 mm x 250 mm, REF 475809, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1531-2011Cylindrical Bullet Nose Reamer 9.5 mm x 250 mm, REF 475807, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1530-2011Cylindrical Bullet Nose Reamer 8.5 mm x 250 mm, REF 475805, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1529-2011Cylindrical Bullet Nose Reamer 8.0 mm x 250 mm, REF 475804, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1528-2011Cylindrical Bullet Nose Reamer 7.5 mm x 250 mm, REF 475803, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-1527-2011Cylindrical Bullet Nose Reamer 7.0 mm x 250 mm, REF 475802, Biomet Orthopedics 66 East...Zimmer GmbHHTO
Z-0926-2011DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook...Wilson-Cook Medical Inc.FGE
Z-0925-2011DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical...Wilson-Cook Medical Inc.FGE
Z-0921-2011Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number...Kimberly-Clark CorporationFYA