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-0691-06 | Tooth bonding resin. Premise Master Syringe Kit, Part Number 32611, Lot Numbers 428730 | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0690-06 | Tooth bonding resin. Nexus 2 Starter Kit, Part Number 31955, Lot Numbers 428570 & 429640 | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0689-06 | Tooth bonding resin. Nexus 2 Kit, Part Number 31954, Lot Number 428572 | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0688-06 | Tooth bonding resin. Optibond Solo Plus Dual Cure Kit, Part Number 31736, Lot Number... | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0687-06 | Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106 | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0686-06 | Tooth bonding resin. Optibond Solo Plus, Part Number 31513, Lot Numbers 427936, 428569, &... | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0674-06 | Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540. | Cook Incorporated | FAD | ||
| Z-0613-06 | BD Xstar Bevel Up Slit Knife 2.8mm , Sterile Catalog Number: 373728 | Becton Dickinson & Co | HNN | ||
| Z-0012-2007 | Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S | Integrated Orbital Implants Inc | HPZ | ||
| Z-0707-06 | ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with... | Medtronic, Inc. | FGE | ||
| Z-1172-06 | Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0... | GE Healthcare | IYN | ||
| Z-0766-06 | System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA... | Baxter Healthcare Renal Div | FKP | ||
| Z-2463-2008 | Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3. | SCC Soft Computer | JQP | ||
| Z-2329-2008 | SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for... | SCC Soft Computer | JQP | ||
| Z-0533-06 | Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the... | Canon Medical Systems USA, Inc. | LLZ | ||
| Z-0928-06 | Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that... | Plus Orthopedics | KTT | ||
| Z-0597-06 | Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use... | Zimmer GmbH | LPH | ||
| Z-0910-06 | Magnetic Resonance Imaging Device | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-1079-06 | Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT) | FUJIFILM Healthcare Americas Corporation | JAK | ||
| Z-1078-06 | Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT) | FUJIFILM Healthcare Americas Corporation | JAK | ||
| Z-0820-06 | VariSource AL13198000, Intralumenal Kit | Alpha Omega Services Inc | JAQ | ||
| Z-0819-06 | KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS Tngue And Soft Tissue Inplant Tubes... | Alpha Omega Services Inc | JAQ | ||
| Z-0818-06 | VariSource AL 13197000, Tongue/Soft Tissue Kit | Alpha Omega Services Inc | JAQ | ||
| Z-0817-06 | KCV0008-001, AOS Intralumenal Kit: Intralumenal Implant Tubes (5EA) | Alpha Omega Services Inc | JAQ | ||
| Z-0816-06 | VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown... | Alpha Omega Services Inc | JAQ | ||
| Z-0815-06 | TIT0001-003, Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body... | Alpha Omega Services Inc | JAQ | ||
| Z-0814-06 | VariSource AL 13199023 Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm... | Alpha Omega Services Inc | JAQ | ||
| Z-0813-06 | TII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed... | Alpha Omega Services Inc | JAQ | ||
| Z-0587-06 | Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model... | Moldex/Metric, Inc. | MSH | ||
| Z-0911-2010 | Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple... | Howmedica Osteonics Corp | JWH | ||
| Z-0910-2010 | Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker... | Howmedica Osteonics Corp | JWH | ||
| Z-0909-2010 | Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes... | Howmedica Osteonics Corp | LPH | ||
| Z-1450-06 | Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma... | Siemens Healthcare Diagnostics Inc. | JGS | ||
| Z-1449-06 | ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma... | Siemens Healthcare Diagnostics Inc. | JGS | ||
| Z-1448-06 | ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma... | Siemens Healthcare Diagnostics Inc. | JGS | ||
| Z-0715-06 | Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and... | Rubicor Medical, Inc. | GEI | ||
| Z-0385-2012 | Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS... | Biomet Microfixation | JEY | ||
| Z-0384-2012 | Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS... | Biomet Microfixation | JEY | ||
| Z-0383-2012 | Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS... | Biomet Microfixation | JEY | ||
| Z-0611-06 | Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729 | DePuy Mitek, Inc. | MAI | ||
| Z-0610-06 | Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728 | DePuy Mitek, Inc. | MAI | ||
| Z-0605-06 | FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes... | Abbott Medical | JJX | ||
| Z-0604-06 | FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control... | Abbott Medical | NBW | ||
| Z-0756-06 | Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet... | AGFA Healthcare Corp. | JAC | ||
| Z-0755-06 | Curix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box | AGFA Healthcare Corp. | JAC | ||
| Z-0754-06 | Cronex 10T, 14x17, Medical Screen Film, X-ray Film, 100 Sheet Box | AGFA Healthcare Corp. | JAC | ||
| Z-0788-06 | Mamoray HDR-C PLUS Mammography film | AGFA Healthcare Corp. | IWZ | ||
| Z-0907-06 | Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white)... | Ethicon, Inc | GAM | ||
| Z-1108-06 | X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US... | Medtronic, Inc. | MCW | ||
| Z-1107-06 | X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US... | Medtronic, Inc. | MCW |