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-0856-06 | Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667 | B & K Medical Systems, Inc. | IYN | ||
| Z-1406-2010 | PrecisePLAN 2.10 Treatment Planning System | Elekta Limited | MUJ | ||
| Z-0869-06 | Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only * Manufactured by... | Kimberly-Clark Corporation | CAZ | ||
| Z-0868-06 | Kimberly Clark * Selective Nerve Block Tray * Single Use * Sterile * Rx only *... | Kimberly-Clark Corporation | CAZ | ||
| Z-0867-06 | Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only * Manufactured by... | Kimberly-Clark Corporation | CAZ | ||
| Z-0866-06 | Kimberly Clark * Nerve Block Tray * Single Use * Sterile * Rx only * Manufactured by... | Kimberly-Clark Corporation | CAZ | ||
| Z-0865-06 | Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by... | Kimberly-Clark Corporation | CAZ | ||
| Z-0864-06 | Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only *... | Kimberly-Clark Corporation | FPK | ||
| Z-0902-06 | Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0901-06 | SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part Number: A23724 | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0900-06 | SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software Version 4.5; Part... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0824-06 | Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to... | Hobbs Medical, Inc. | KOG | ||
| Z-1261-2007 | Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw... | Howmedica Osteonics Corp | MEH | ||
| Z-0863-06 | CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219)... | Boston Scientific Corporation | NIK | ||
| Z-0205-2007 | Access Point Medical Canes, Quad Cane, Large Base - Gold, Product Code CN11070B, and... | Access Point Medical, LLC | IPS | ||
| Z-0204-2007 | Access Point Medical Canes, Quad Cane, Small Base - Gold, Product Code CN11050B, and... | Access Point Medical, LLC | IPS | ||
| Z-0203-2007 | Access Point Medical Canes, Quad Cane, Medium Base (Gold, Chrome), Product Code CN11050... | Access Point Medical, LLC | IPS | ||
| Z-0202-2007 | Access Point Medical Canes, Cane, Off-Set Crook w/Strap-Black, Product Code CN10051... | Access Point Medical, LLC | IPS | ||
| Z-0769-06 | Storz Documentation Cart with Articulating Arm, Model Number 9601F | Karl Storz Endoscopy-America, Inc. | KOG | ||
| Z-0809-06 | AXIOM Artis X-ray systems running software versions VB11K and VB22G | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0621-06 | Fischer Cone Biopsy Excisor Model: 900-158 | CooperSurgical, Inc. | HGI | ||
| Z-0620-06 | Fischer Cone Biopsy Excisor Model: 900-157 | CooperSurgical, Inc. | HGI | ||
| Z-0619-06 | Fischer Cone Biopsy Excisor - Dual Sets Model: 900-156 | CooperSurgical, Inc. | HGI | ||
| Z-0618-06 | Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155 | CooperSurgical, Inc. | HGI | ||
| Z-0617-06 | Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154 | CooperSurgical, Inc. | HGI | ||
| Z-0616-06 | Fischer Cone Biopsy Excisor - Large Model: 900-152 | CooperSurgical, Inc. | HGI | ||
| Z-0615-06 | Fischer Cone Biopsy Excisor - Medium Model: 900-151 | CooperSurgical, Inc. | HGI | ||
| Z-0614-06 | Fischer Cone Biopsy Excisor - Small Model: 900-150 | CooperSurgical, Inc. | HGI | ||
| Z-0796-06 | SOMATOM CT System Sensation Open. Computed tomography x-ray system. | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0795-06 | SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system. | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0794-06 | SOMATOM CT System Sensation 16. Computed tomography x-ray system. | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0793-06 | SOMATOM CT System Emotion 16. Computed tomography x-ray system. | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0849-06 | Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number... | Medtronic Neurosurgery | GXL | ||
| Z-0759-06 | The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with... | Advanced Bionics LLC | MCM | ||
| Z-0860-06 | ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in... | Abbott Medical | LIG | ||
| Z-0912-06 | ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The... | Medtronic, Inc. | FGE | ||
| Z-0758-06 | The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with... | Advanced Bionics LLC | MCM | ||
| Z-0768-06 | TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor | Abbott Medical | FLL | ||
| Z-0767-06 | STS-400 Level1 Skin Temperature Sensor with 400 Series Thermistor | Abbott Medical | FLL | ||
| Z-1247-06 | Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25... | Instrumentation Laboratory Co. | GJS | ||
| Z-1246-06 | HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of... | Instrumentation Laboratory Co. | GJS | ||
| Z-0714-06 | Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080 | Abbott Medical | BTO | ||
| Z-0077-2007 | VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog #... | Ortho-Clinical Diagnostics, Inc. | JQP | ||
| Z-0898-06 | GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option... | GE Healthcare | MQB | ||
| Z-0897-06 | GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option... | GE Healthcare | MQB | ||
| Z-0789-06 | iLab Utrasound Imaging System, software controlled Imaging Catheter. | Boston Scientific Corporation | DQO | ||
| Z-0896-06 | GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile... | GE Healthcare | MQB | ||
| Z-0872-06 | Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog #... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | HWC | ||
| Z-0693-06 | Tooth bonding resin. Premise Starter Unidose Kit, Part Number 32684, Lot Numbers 427915 | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0692-06 | Tooth bonding resin. Premise Master Unidose Kit, Part Number 32612, Lot Numbers 428576 | Sybron Dental Specialties, Inc. | KLE |