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-1444-2011 | Curlin Infusion Administration Set, REF 340-4128, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1443-2011 | Curlin Infusion Administration Set, REF 340-4127, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1442-2011 | Curlin Infusion Administration Set, REF 340-4126, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1441-2011 | Curlin Infusion Administration Set, REF 340-4115, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1440-2011 | Curlin Infusion Administration Set, REF 340-4114, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1439-2011 | Curlin Infusion Administration Set, REF 340-4111, Sterile EO, Zevex, Inc., 4314 Zevex... | Zevex, Inc. | FRN | ||
| Z-1879-2011 | King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405, Manufacturer: King Systems... | King Systems Corporation. | CAE | ||
| Z-1878-2011 | King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems... | King Systems Corporation. | CAE | ||
| Z-0590-2012 | DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip)... | Boston Scientific Corporation | MSD | ||
| Z-0589-2012 | DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip)... | Boston Scientific Corporation | MSD | ||
| Z-0588-2012 | DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip)... | Boston Scientific Corporation | MSD | ||
| Z-0587-2012 | DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip)... | Boston Scientific Corporation | MSD | ||
| Z-0586-2012 | DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip)... | Boston Scientific Corporation | MSD | ||
| Z-2809-2011 | ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO... | Zevex, Inc. | FRN | ||
| Z-2808-2011 | ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4175, Sterile EO... | Zevex, Inc. | FRN | ||
| Z-2807-2011 | ***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4119, Sterile EO... | Zevex, Inc. | FRN | ||
| Z-2196-2011 | Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28... | Edwards Lifesciences LLC | DWF | ||
| Z-1618-2011 | STA-Flex SUBTALAR SCREW, 13 mm x 19 mm, REF 982367, Sterile, Biomet Sports Medicine, 56... | Zimmer GmbH | HWC | ||
| Z-1617-2011 | STA-Flex SUBTALAR SCREW, 12 mm x 18 mm, REF 982366, Sterile, Biomet Sports Medicine, 56... | Zimmer GmbH | HWC | ||
| Z-1616-2011 | STA-Flex SUBTALAR SCREW, 11 mm x 17 mm, REF 982365, Sterile, Biomet Sports Medicine, 56... | Zimmer GmbH | HWC | ||
| Z-1615-2011 | STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile, Biomet Sports Medicine, 56... | Zimmer GmbH | HWC | ||
| Z-1614-2011 | STA-Flex SUBTALAR SCREW, 9 mm x 15 mm, REF 982363, Sterile, Biomet Sports Medicine, 56... | Zimmer GmbH | HWC | ||
| Z-1613-2011 | STA-Flex SUBTALAR SCREW, 8 mm x 14 mm, REF 982362, Sterile, Biomet Sports Medicine, 56... | Zimmer GmbH | HWC | ||
| Z-1612-2011 | STA-Flex SUBTALAR SCREW, 7 mm x 13 mm, REF 982361, Sterile, Biomet Sports Medicine, 56... | Zimmer GmbH | HWC | ||
| Z-1854-2011 | HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB... | Accriva Diagnostics, Inc. | GKR | ||
| Z-1607-2011 | CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover... | CIVCO Medical Instruments Co., Inc. | ITX | ||
| Z-0398-2012 | OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories. | Hill-Rom Inc. | FQO | ||
| Z-0397-2012 | OR table TITAN U, Surgical Table. Surgical bed with Orthopedic Accessories. | Hill-Rom Inc. | FQO | ||
| Z-0396-2012 | OR table TITAN T, Surgical Table. Surgical bed with Orthopedic Accessories. | Hill-Rom Inc. | FQO | ||
| Z-0395-2012 | OR table TITAN Automatic, Surgical Table. Surgical bed with Orthopedic Accessories. | Hill-Rom Inc. | FQO | ||
| Z-0394-2012 | OR table TITAN, Surgical Table. Surgical bed with Orthopedic Accessories. | Hill-Rom Inc. | FQO | ||
| Z-2290-2011 | Case Label: REF UT8155 Urethal Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs... | Nurse Assist, LLC | FCM | ||
| Z-2289-2011 | Case Label: REF UT8150 Urethral Insertion Tray 14 Fr Red Rubber Catheter with PVP Swabs... | Nurse Assist, LLC | FCM | ||
| Z-2288-2011 | Case Label: REF UT 8145 Urethral Insertion Tray 14Fr Nelaton PVC Catheter with BZK Swabs... | Nurse Assist, LLC | FCM | ||
| Z-2287-2011 | Case Label: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with PVP Swabs... | Nurse Assist, LLC | FCM | ||
| Z-2286-2011 | Case Label: REF UT7035 Catheter Insertion Tray 30cc Pre-Filled Syringe with BZK Swabs... | Nurse Assist, LLC | KOD | ||
| Z-2285-2011 | Case Label: REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs... | Nurse Assist, LLC | KOD | ||
| Z-2284-2011 | Case Label: REF UT7015 Catheter Insertion Tray 10cc Pre-Filled Syringe with BZK Swabs... | Nurse Assist, LLC | KOD | ||
| Z-2283-2011 | Case Label: REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs... | Nurse Assist, LLC | KOD | ||
| Z-2282-2011 | Case Label: REORDER NO. 7504 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter... | Nurse Assist, LLC | FCM | ||
| Z-2281-2011 | Case Label: REORDER NO. 7503 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter... | Nurse Assist, LLC | FCM | ||
| Z-2280-2011 | Case Label: REORDER NO. 7502 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber... | Nurse Assist, LLC | FCM | ||
| Z-2279-2011 | Case Label: REORDER NO. 7501 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic... | Nurse Assist, LLC | FCM | ||
| Z-2278-2011 | Case Label: REORDER NO. 7500 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/o Plastic... | Nurse Assist, LLC | FCM | ||
| Z-2277-2011 | Case Label: REORDER NO. 7402 (STERILE) WELCON BRAND URETHRAL CATHETER KIT (Female) nurse... | Nurse Assist, LLC | FCM | ||
| Z-2276-2011 | REORDER NO. 7305WTU (NON-STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml... | Nurse Assist, LLC | FCM | ||
| Z-2275-2011 | Case Label: REORDER NO. 7305 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter... | Nurse Assist, LLC | FCM | ||
| Z-2274-2011 | Case Label: REORDER NO. 7304 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter... | Nurse Assist, LLC | KOD | ||
| Z-2273-2011 | Case Label: REORDER NO. 7303 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter... | Nurse Assist, LLC | KOD | ||
| Z-2272-2011 | Case Label: REORDER NO. 7302 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber... | Nurse Assist, LLC | KOD |