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-0992-05 | Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018. | Warsaw Orthopedic, Inc. | HRX | ||
| Z-1041-05 | Beckman Coulter 1500 Series Hematology Automation System; Part Number: 988609 (LH Basic... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0991-05 | Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016. | Warsaw Orthopedic, Inc. | HRX | ||
| Z-0960-05 | 10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener... | Abbott Medical | LNO | ||
| Z-1319-06 | D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers. | Radiometer America, Inc | CHL | ||
| Z-1318-06 | Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series. | Radiometer America, Inc | CHL | ||
| Z-1317-06 | Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series. | Radiometer America, Inc | CHL | ||
| Z-0908-05 | CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene... | Boston Scientific Corporation | NIK | ||
| Z-0984-05 | LIFEPAK 20 defbrillator/monitor | Physio Control, Inc. | LDD | ||
| Z-1017-05 | Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus... | Abbott Medical | NIK | ||
| Z-0956-05 | CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model... | Boston Scientific Corporation | LWP | ||
| Z-0955-05 | VITALITY AVT, model A135 and model A155. Implantable Cardioverter Defibrillator... | Boston Scientific Corporation | LWP | ||
| Z-0954-05 | VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using... | Boston Scientific Corporation | LWP | ||
| Z-0907-05 | CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy... | Boston Scientific Corporation | NIK | ||
| Z-0906-05 | Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD)... | Boston Scientific Corporation | KRG | ||
| Z-1104-05 | Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor. | Datascope Corp. | DRT | ||
| Z-1065-05 | CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy... | Boston Scientific Corporation | NIK | ||
| Z-1064-05 | PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have... | Boston Scientific Corporation | KRG | ||
| Z-0033-06 | Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management... | Baxter Healthcare Corporation | NSX | ||
| Z-1395-05 | Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX... | Baxter Healthcare Renal Div | KDI | ||
| Z-0942-05 | AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing... | Qualitest Pharmaceuticals Inc | FMF | ||
| Z-1394-05 | Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3... | Baxter Healthcare Renal Div | JPI | ||
| Z-1089-05 | Baxter 6060E Epidural Infusion Pump, product code 2L9351 and 606000-40EL; Manufactured by... | Baxter Healthcare Corporation | FRN | ||
| Z-1443-05 | Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set... | Boston Scientific Corporation | DYB | ||
| Z-1442-05 | Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead... | Boston Scientific Corporation | DYB | ||
| Z-0987-05 | CLARIS Cleaning and Soaking Solution, 4 fl. oz. | Advanced Medical Optics, Inc. | LPN | ||
| Z-1441-05 | Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array... | Boston Scientific Corporation | DYB | ||
| Z-1088-05 | Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832, 606000-40, 606000-40L... | Baxter Healthcare Corporation | FRN | ||
| Z-0990-05 | Axiom Aristos FX. Model number 74 14 803 | Siemens Medical Solutions USA, Inc. | KPR | ||
| Z-0989-05 | Axiom Aristos MX/VX. Model number 58 95 003 | Siemens Medical Solutions USA, Inc. | KPR | ||
| Z-0988-05 | Axiom Aristos TX. Model number 58 94 873 Radiology system | Siemens Medical Solutions USA, Inc. | KPR | ||
| Z-0936-05 | ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System)... | Medtronic, Inc. | FGE | ||
| Z-0935-05 | ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System)... | Medtronic, Inc. | FGE | ||
| Z-0934-05 | ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System)... | Medtronic, Inc. | FGE | ||
| Z-0933-05 | Radical Handheld Pulse Oximeter | Masimo Corporation | DQA | ||
| Z-1320-06 | ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on... | Radiometer America, Inc | CHL | ||
| Z-1082-05 | Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The... | Del Laboratories Inc. | EFW | ||
| Z-0941-05 | Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable Single Use... | Wilson-Cook Medical Inc. | KNT | ||
| Z-0940-05 | CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between... | Wilson-Cook Medical Inc. | FGE | ||
| Z-0980-05 | LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; All One Touch... | Lifescan, Inc. | NBW | ||
| Z-1371-05 | Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100... | The Medical Device Group, Inc. | MOD | ||
| Z-1063-05 | Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in... | Encore Medical, LP | MRA | ||
| Z-0946-05 | Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter... | Boston Scientific Corporation | LLD | ||
| Z-0945-05 | Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog... | Boston Scientific Corporation | LLD | ||
| Z-0944-05 | Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane... | Boston Scientific Corporation | LLD | ||
| Z-0054-06 | FreeStyle Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes... | Abbott Medical | NBW | ||
| Z-1571-05 | Ultrasound probe cover, sterile. Catalog No. 910811. | North Coast Medi-Tek | KKX | ||
| Z-0053-06 | SofTrac Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care... | Abbott Medical | NBW | ||
| Z-0052-06 | Easy Glucose Monitoring System; Recalling Firm/Manufacturer Abbott Diabetes Care, Inc... | Abbott Medical | NBW | ||
| Z-0051-06 | Xtra Classic Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes... | Abbott Medical | NBW |