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-0389-2010 | Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew... | Smith & Nephew, Inc. | JDI | ||
| Z-1673-2009 | Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal... | Volk Optical Inc | KYB | ||
| Z-1233-2009 | Siemens Mammomat Novation DR, full field digital mammography system. Model Number... | Siemens Medical Solutions USA, Inc. | MUE | ||
| Z-1016-2010 | Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model... | Biogenex Laboratories, Inc. | KEY | ||
| Z-1038-2009 | Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-1037-2009 | Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-1820-2009 | LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew... | Smith & Nephew, Inc. | JWH | ||
| Z-1819-2009 | LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew... | Smith & Nephew, Inc. | JWH | ||
| Z-1704-2009 | IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip... | Smith & Nephew, Inc. | LXH | ||
| Z-1902-2010 | VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-1901-2010 | VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-0974-2009 | Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting... | Zimmer GmbH | LYC | ||
| Z-0822-2010 | Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit... | Ortho-Clinical Diagnostics, Inc. | KIR | ||
| Z-0479-2011 | Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva... | Philips North America LLC | KPR | ||
| Z-1318-2009 | Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system | Siemens Medical Solutions USA, Inc. | JAQ | ||
| Z-1263-2009 | Carina Home Ventilator. The device is used as a continuous respirator/ventilator for... | Draeger, Inc. | CBK | ||
| Z-1059-2009 | AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy... | Wilson-Cook Medical Inc. | KNS | ||
| Z-2180-2011 | Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics... | Digisonics, Inc | LLZ | ||
| Z-2021-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON... | Bard Access Systems, Inc. | KGC | ||
| Z-2020-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON... | Bard Access Systems, Inc. | KGC | ||
| Z-2019-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON... | Bard Access Systems, Inc. | KGC | ||
| Z-2018-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON... | Bard Access Systems, Inc. | KGC | ||
| Z-2017-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE... | Bard Access Systems, Inc. | KGC | ||
| Z-1923-2011 | Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift... | Penner Patient Care, Inc | FNG | ||
| Z-1922-2011 | Penner Manufacturing Transfer Electric Pacific Chair, Patient Transfer/Lift System... | Penner Patient Care, Inc | FNG | ||
| Z-1921-2011 | Penner Manufacturing Transfer Electric Superior end entry with scale, Patient... | Penner Patient Care, Inc | FNG | ||
| Z-1920-2011 | Penner Manufacturing Transfer Electric Superior left entry with scale, Patient... | Penner Patient Care, Inc | FNG | ||
| Z-1919-2011 | Penner Manufacturing Transfer Electric Superior right entry with scale, Patient... | Penner Patient Care, Inc | FNG | ||
| Z-1918-2011 | Penner Manufacturing Transfer Electric Superior end entry, Patient Transfer/Lift System... | Penner Patient Care, Inc | FNG | ||
| Z-1917-2011 | Penner Manufacturing Transfer Electric Superior left entry, Patient Transfer/Lift System... | Penner Patient Care, Inc | FNG | ||
| Z-1916-2011 | Penner Manufacturing Transfer Electric Superior right entry, Patient Transfer/Lift... | Penner Patient Care, Inc | FNG | ||
| Z-1915-2011 | Penner Manufacturing Transfer Electric Bariatric with Scale, Patient Transfer/Lift... | Penner Patient Care, Inc | FNG | ||
| Z-1914-2011 | Penner Manufacturing Transfer Electric Cascade with Scale, Patient Transfer/Lift System... | Penner Patient Care, Inc | FNG | ||
| Z-2594-2011 | Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. Product... | Elekta Limited | MUJ | ||
| Z-1913-2011 | Penner Manufacturing Bariatric Patient Transfer/Lift System, Cascade Transfer, Models... | Penner Patient Care, Inc | FNG | ||
| Z-1912-2011 | Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models... | Penner Patient Care, Inc | FNG | ||
| Z-1911-2011 | Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models 380000-1... | Penner Patient Care, Inc | FNG | ||
| Z-1212-2010 | Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The... | Pro-Dex Inc | DZE | ||
| Z-1436-2012 | Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order... | Baxter Corporation Englewood | LNX | ||
| Z-1236-2009 | Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions... | Cerner Corporation | JQP | ||
| Z-1051-2009 | AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM... | Abbott Medical | MMI | ||
| Z-1050-2009 | AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin... | Abbott Medical | DDR | ||
| Z-1049-2009 | AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is... | Abbott Medical | CGN | ||
| Z-1048-2009 | AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0... | Abbott Medical | LOM | ||
| Z-1047-2009 | AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG... | Abbott Medical | LFZ | ||
| Z-1046-2009 | AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a... | Abbott Medical | LOM | ||
| Z-1035-2009 | Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021 | Integra LifeSciences Corporation | MDD | ||
| Z-1034-2009 | Integra Mosaik Putty, 15cc, Catalog # PTY10256 Integra Lifesciences, Plainsboro, NJ | Integra LifeSciences Corporation | MQV | ||
| Z-1906-2009 | Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. The intended use of the... | Revvity Health Sciences, Inc. | JQP | ||
| Z-1905-2009 | Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The... | Revvity Health Sciences, Inc. | JQP |