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-0489-2010 | LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE... | Biomet Microfixation | HWC | ||
| Z-0133-2010 | VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by... | Varian Medical Systems, Inc. | IYE | ||
| Z-0816-2012 | Sechrist Hyperbaric Chamber Gurney. The Sechrist Hyperbaric Chamber Gurney is an... | Sechrist Industries Inc | FPO | ||
| Z-0118-2010 | Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0117-2010 | Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0116-2010 | Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0115-2010 | Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0114-2010 | Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0113-2010 | Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0112-2010 | Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0111-2010 | Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0110-2010 | Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0109-2010 | Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0108-2010 | Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number... | Synthes GmbH | MQP | ||
| Z-0269-2010 | Norian CRS Rotary Mixer Cement 10cc sterile | Synthes GmbH | GXP | ||
| Z-0139-2010 | John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube. | GF Health Products, Inc. | BTO | ||
| Z-2095-2010 | Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a... | Medacta USA, Inc. | JWH | ||
| Z-1316-2010 | ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number... | Abbott Medical | JJE | ||
| Z-0414-2010 | STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for... | STERIS Corporation | FTD | ||
| Z-0068-2010 | Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be... | Boston Scientific Corporation | MAF | ||
| Z-0419-2010 | Philips Lifeline Personal Help Button Pendant Classic and Slimline Style. | Philips Lifeline Inc | ILQ | ||
| Z-0121-2010 | Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1631-2010 | Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline... | Boston Scientific Corporation | LWS | ||
| Z-0191-2010 | Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports... | Zimmer GmbH | HWC | ||
| Z-0812-2010 | i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of... | Abbott Medical | CGA | ||
| Z-0131-2010 | This device is not approved in the United States. Medtronic Virtuoso VR, D164VWC... | Medtronic, Inc. | LWS | ||
| Z-0130-2010 | This device is not approved in the United States. Medtronic Virtuoso DR, D164AWG... | Medtronic, Inc. | LWS | ||
| Z-0129-2010 | Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter... | Medtronic, Inc. | LWS | ||
| Z-0074-2010 | Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867... | Sybron Dental Specialties, Inc. | EMA | ||
| Z-0128-2010 | Medtronic Virtuoso DR, D154AWG, Dual Chamber implantable cardioverter defibrillator with... | Medtronic, Inc. | LWS | ||
| Z-0127-2010 | This device is not approved in the United States. Medtronic Concerto, C174AWK. Dual... | Medtronic, Inc. | NIK | ||
| Z-0126-2010 | Medtronic Concerto, C154DWK, Dual chamber implantable cardioverter defibrillator with... | Medtronic, Inc. | NIK | ||
| Z-0608-2010 | Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner. | Solafeet, Inc. | REG | ||
| Z-0974-2010 | Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on... | Sigma-Aldrich Manufacturing, LLC | JCF | ||
| Z-0391-2010 | Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset)... | Howmedica Osteonics Corp | JDG | ||
| Z-0390-2010 | Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset)... | Howmedica Osteonics Corp | JDG | ||
| Z-2252-2009 | Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. The Flexiflo Quantum... | Ross Products Division Abbott Laboratories | LZH | ||
| Z-1430-2010 | Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model... | TORNIER Inc. | HTW | ||
| Z-0417-2010 | AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic... | Smith & Nephew, Inc. | NBH | ||
| Z-0416-2010 | AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an... | Smith & Nephew, Inc. | NBH | ||
| Z-0082-2010 | SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853. Synthes Titanium... | Synthes GmbH | HWE | ||
| Z-0081-2010 | SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM, Catalog #... | Synthes GmbH | JEY | ||
| Z-0080-2010 | SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM, Catalog #... | Synthes GmbH | JEY | ||
| Z-0079-2010 | SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog #... | Synthes GmbH | JEY | ||
| Z-0078-2010 | SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/39MM, Catalog #... | Synthes GmbH | JEY | ||
| Z-0077-2010 | SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900 | Synthes GmbH | HTD | ||
| Z-0076-2010 | SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL, Catalog #... | Synthes GmbH | HTC | ||
| Z-0075-2010 | SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix... | Synthes GmbH | HTD | ||
| Z-0415-2010 | AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an... | Smith & Nephew, Inc. | NBH | ||
| Z-0161-2010 | Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per... | Medical Components, Inc. | MSD |