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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0530-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653... | Biomet Microfixation | KDD | ||
| Z-0938-2011 | Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc... | Flowcardia, Inc. | DQY | ||
| Z-1022-2010 | SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634. | Hsmg, Inc. D/b/a Smartinfuser USA | MEB | ||
| Z-1021-2010 | SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and... | Hsmg, Inc. D/b/a Smartinfuser USA | MEB | ||
| Z-1169-2010 | Aquilion 64 CT System; Model number TSX-101 A/J The product is an x-ray device that... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1168-2010 | Aquilion 32 CT System; Model number TSX-101 A/K The product is an x-ray device that... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1167-2010 | Aquilion 64 CT System; Model number TSX-101 A/H The product is an x-ray device that... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1166-2010 | Aquilion 32 CT System; Model number TSX-101 A/I The product is an x-ray device that... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1165-2010 | Aquilion 64 CT System; Model number TSX-101 A/D The product is an x-ray device that... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1164-2010 | Aquilion 32 CT System; Model number TSX-101 A/E The product is an x-ray device that... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1254-2009 | AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-1253-2009 | AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as... | Siemens Medical Solutions USA, Inc. | JAA | ||
| Z-1265-2009 | Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is... | Dental Imaging Technologies Corporation | MUH | ||
| Z-1012-2009 | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm... | Boston Scientific Corporation | LQR | ||
| Z-1011-2009 | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr... | Boston Scientific Corporation | LQR | ||
| Z-1010-2009 | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr... | Boston Scientific Corporation | LQR | ||
| Z-0764-2010 | Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm... | Argon Medical Devices, Inc | DRE | ||
| Z-1684-2009 | Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper... | Howmedica Osteonics Corp | MEH | ||
| Z-1683-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray. Hip stems... | Howmedica Osteonics Corp | MEH | ||
| Z-1682-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray. Hip stems... | Howmedica Osteonics Corp | MEH | ||
| Z-1681-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray. Hip stems... | Howmedica Osteonics Corp | MEH | ||
| Z-1680-2009 | Super Secur Fit Plus. Hip stems are single use devices intended for cementless... | Howmedica Osteonics Corp | MEH | ||
| Z-1388-2009 | Omniflex-HA Hip Stem W/C Taper. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | KWL | ||
| Z-1387-2009 | Super Secur Fit Plus. Hip stems are single use devices intended for cementless... | Howmedica Osteonics Corp | MEH | ||
| Z-1386-2009 | Super Secur Fit Plus. Hip stems are single use devices intended for cementless... | Howmedica Osteonics Corp | MEH | ||
| Z-1385-2009 | Super Secur Fit Plus. Hip stems are single use devices intended for cementless... | Howmedica Osteonics Corp | MEH | ||
| Z-1384-2009 | Super Secur Fit Plus. Hip stems are single use devices intended for cementless... | Howmedica Osteonics Corp | MEH | ||
| Z-1383-2009 | Super Secur Fit Plus. Hip stems are single use devices intended for cementless... | Howmedica Osteonics Corp | MEH | ||
| Z-1382-2009 | Short Citation TMZF HA Hip Stem - Right; Hydroxylapatite Coated, Titanium Plasma... | Howmedica Osteonics Corp | MEH | ||
| Z-1381-2009 | Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | MEH | ||
| Z-1380-2009 | Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | MEH | ||
| Z-1379-2009 | Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | MEH | ||
| Z-1378-2009 | Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | MEH | ||
| Z-1377-2009 | Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | MEH | ||
| Z-1376-2009 | Citation TMZF HA Hip Stem - LT. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | MEH | ||
| Z-1375-2009 | Citation TMZF HA Hip Stem - LT. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | MEH | ||
| Z-1374-2009 | Citation TMZF HA Hip Stem - LT. Hip stems are single use devices intended for... | Howmedica Osteonics Corp | MEH | ||
| Z-1373-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40... | Howmedica Osteonics Corp | MEH | ||
| Z-1372-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40... | Howmedica Osteonics Corp | MEH | ||
| Z-1371-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40... | Howmedica Osteonics Corp | MEH | ||
| Z-1370-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40... | Howmedica Osteonics Corp | MEH | ||
| Z-1369-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40... | Howmedica Osteonics Corp | MEH | ||
| Z-1368-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40... | Howmedica Osteonics Corp | MEH | ||
| Z-1367-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40... | Howmedica Osteonics Corp | MEH | ||
| Z-1366-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper... | Howmedica Osteonics Corp | MEH | ||
| Z-1365-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper... | Howmedica Osteonics Corp | MEH | ||
| Z-1364-2009 | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper... | Howmedica Osteonics Corp | MEH | ||
| Z-1363-2009 | Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper... | Howmedica Osteonics Corp | MEH | ||
| Z-1362-2009 | Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper... | Howmedica Osteonics Corp | MEH | ||
| Z-1361-2009 | Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper... | Howmedica Osteonics Corp | MEH |