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-0516-04 | CryoValve, Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0250-04 | Solar 9500 Information Monitor with software version 3A. | GE Medical Systems Information Technologies, Inc. | MHX | ||
| Z-0264-04 | CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes. | Bausch & Lomb Incorporated | HJM | ||
| Z-0300-04 | MVP-10 Pediatric/ Neonatal Volume Ventilator | Bio-Med Devices, Inc. | MNT | ||
| Z-0261-04 | Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike... | Vital Concepts, Inc. | BYY | ||
| Z-0260-04 | Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation... | Vital Concepts, Inc. | BYY | ||
| Z-0259-04 | Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing... | Vital Concepts, Inc. | BYY | ||
| Z-0211-04 | C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step... | Interpore Cross International Inc | DKA | ||
| Z-0227-04 | Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped... | Boehringer Laboratories, LLC | CAC | ||
| Z-0210-04 | Exacta-Mix 2400 pharmacy compounding system. | Baxter Corporation Englewood | NEP | ||
| Z-0258-04 | Irrigation aspiration system with double spike tubing and 33 cm probe, latex free... | Vital Concepts, Inc. | BYY | ||
| Z-0348-04 | Platelia Aspergillus EIA | Bio-Rad Laboratories Inc. | NOM | ||
| Z-0184-04 | Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A2 | Allen Medical Systems, Inc. | FPS | ||
| Z-0183-04 | Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1 | Allen Medical Systems, Inc. | FPS | ||
| Z-0182-04 | Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table... | Allen Medical Systems, Inc. | FPS | ||
| Z-0159-04 | UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile... | Merit Medical Systems, Inc. | DQO | ||
| Z-0158-04 | UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit... | Merit Medical Systems, Inc. | DQO | ||
| Z-0209-04 | Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests... | Abbott Medical | LOM | ||
| Z-0257-04 | Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-0256-04 | Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-0255-04 | Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-0254-04 | Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-0167-04 | CryoValve Pulmonary Valve & Conduct | Artivion, Inc. | MIE | ||
| Z-1096-04 | DataLink 2000 Data Manager | Siemens Healthcare Diagnostics Inc. | |||
| Z-0273-04 | Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm... | Remel Inc | LJG | ||
| Z-0208-04 | AEROSET Phenobarbital, LN 1E08-01 | Abbott Medical | LGQ | ||
| Z-0251-04 | PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each... | Owens & Minor Distribution, Inc. | FTL | ||
| Z-0243-04 | Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six... | Medtronic, Inc. | FTL | ||
| Z-0627-05 | Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582. | Kulzer GmbH | ELW | ||
| Z-0626-05 | Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584. | Kulzer GmbH | ELW | ||
| Z-0625-05 | Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583. | Kulzer GmbH | ELW | ||
| Z-0624-05 | Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. | Kulzer GmbH | ELW | ||
| Z-0231-04 | Fix pins associated with Stealth Station Treatment Guidance Platform | Medtronic Navigation, Inc | HAW | ||
| Z-0249-04 | PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each... | McKesson General Medical Corporation | FTL | ||
| Z-0163-04 | ICON 25 hCG Test Kit | Siemens Healthcare Diagnostics Inc. | JHI | ||
| Z-0176-03 | BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic... | Varian Medical Systems, Inc. | LNX | ||
| Z-0152-04 | 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y... | Maximus Medical Products Inc | FPA | ||
| Z-0246-04 | Product is a surgical device packaged in a box which is labeled as Sterile with the... | Q-Med Corporation | FTL | ||
| Z-0177-04 | CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code... | Baxter Healthcare Corporation | KDI | ||
| Z-0274-04 | The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories... | Abbott Medical | JJE | ||
| Z-0269-04 | Spacelabs flat panel monitor, Model 91415-A | GE Healthcare | DXJ | ||
| Z-0181-04 | Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers)... | Bock,Otto,Orthopedic Ind,Inc | IOR | ||
| Z-0316-04 | VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2... | bioMerieux, Inc. | LSR | ||
| Z-0568-04 | The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the... | Cardiocommand Inc. | LPA | ||
| Z-0145-04 | Portable Oxygen Analyzer | Teledyne Analytical Instruments | CCL | ||
| Z-0001-04 | Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio... | Sedecal USA, Inc | IZL-- | ||
| Z-0244-04 | NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for... | Welch Allyn Inc | DXQ | ||
| Z-1392-04 | Ref. No. 533735 and 534735 Hemoclip Plus, 25 Small Titanium Clips, Cartridge; Ref. No... | Teleflex Medical | HBT | ||
| Z-1391-04 | Ref. No. 533702 Hemoclip Plus, 25 Medium Titanium Clips, No Tape; Ref. No. 533737... | Teleflex Medical | HBT | ||
| Z-1390-04 | Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and Ref. No. 523670... | Teleflex Medical | HBT |