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-0428-03 | COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0427-03 | COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0426-03 | COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0425-03 | COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0402-03 | LifeStyles Assorted Colors Condoms with Spermicide | Ansell Healthcare Products LLC | LTZ | ||
| Z-0401-03 | Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted... | Ansell Healthcare Products LLC | HIS | ||
| Z-0423-03 | Misys Laboratory versions 5.23 and 5.3 | CliniSys, Inc | |||
| Z-1374-04 | ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496. | Remel Inc | MHI | ||
| Z-1229-03 | Gyroscan Intera 1.0T & 1.5T | Philips North America LLC | LNH | ||
| Z-1228-03 | Gyroscan NT-Intera | Philips North America LLC | LNH | ||
| Z-1227-03 | Gyroscan ACS-NT with software versions R6x, R7x, R8x | Philips North America LLC | LNH | ||
| Z-0157-03 | Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital... | GE Healthcare | 90LMA | ||
| Z-0593-03 | JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion... | Jomed Catheters, Inc. | |||
| Z-0592-03 | Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon... | Boston Scientific Corporation | DQX | ||
| Z-0345-03 | Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media... | Becton Dickinson & Co | JTY | ||
| Z-0612-03 | SKBM Microkeratome cutting tool | Alcon Laboratories | HNO | ||
| Z-0422-03 | Misys Laboratory version 5.3 | CliniSys, Inc | JQP | ||
| Z-0808-03 | Portex 1st Response Adult Manual Resuscitators Ref: 8506P | Abbott Medical | BTM | ||
| Z-0810-03 | Portex 1st Response Adult Manual Resuscitators Ref: 8503P | Abbott Medical | BTM | ||
| Z-0809-03 | Portex 1st Response Adult Manual Resuscitators Ref: 8500P | Abbott Medical | BTM | ||
| Z-0605-03 | Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter... | Baxter Healthcare Corporation | KDI | ||
| Z-0420-03 | Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use... | Medtronic, Inc. | GCB-- | ||
| Z-0400-03 | Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua... | My Cosmetics Inc | LPL | ||
| Z-0424-03 | X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive... | X-Cel X-Ray Corp | KPR-- | ||
| Z-0342-03 | Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Lot 1170119, Expiration 2007/10, BC... | Alcon Laboratories | LPL | ||
| Z-0350-03 | Citation TMZF HA Hip Stem Left (Femoral Hip Prosthesis) Catalog No. 6265-5106 | Howmedica Osteonics Corp | MEH | ||
| Z-0349-03 | Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116 | Howmedica Osteonics Corp | MEH | ||
| Z-0351-03 | Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47 | Medtronic Cardiac Surgery Technologies | 74 | ||
| Z-0419-03 | Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend... | Medtronic Powered Surgical Solutions | HBB | ||
| Z-0985-02 | Block Mold Cutter, Model 8532, Version 1.2. | Multidata Systems Intl Corp | |||
| Z-0418-03 | COULTER LH 700 Series Hematology Analyzers | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0417-03 | COULTER LH 700 Series Hematology Analyzers | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0416-03 | COULTER LH 700 Series Hematology Analyzers | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0415-03 | COULTER LH 700 Series Hematology Analyzers | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0403-03 | Precision PCx Test Strips Part Number: 98757-12 | Abbott Medical | CGA | ||
| Z-0413-03 | Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725 | Smith & Nephew, Inc. | HRX | ||
| Z-0408-03 | The following brand name labeled products are under recall (all catalog numbers and all... | Nipro Medical Corporation | FIE | ||
| Z-0404-03 | Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250 | Elan Diagnostics | CHH | ||
| Z-0298-03 | Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure... | Terumo Cardiovascular Systems Corporation | DTR | ||
| Z-0544-03 | 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End | Surgical Specialties Corp | GEA | ||
| Z-0543-03 | 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End | Surgical Specialties Corp | GEA | ||
| Z-0341-03 | Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1... | Abbott Medical | DXY | ||
| Z-0550-03 | Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal | Ascension Orthopedics, Inc. | --- | ||
| Z-0549-03 | Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The... | Ascension Orthopedics, Inc. | --- | ||
| Z-0728-03 | SurgiFrost Cryosurgical Probes | Varian Medical Systems, Inc. | GEH | ||
| Z-0325-03 | Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus. | CliniSys, Inc | JQP | ||
| Z-0647-03 | Misys Laboratory, version 5.3 with Reference Laboratory Interface | CliniSys, Inc | JQP | ||
| Z-0521-03 | Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FPA | ||
| Z-0520-03 | Baxter 36'' Micro-Volume Extension Set, catalog 2N3347; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FPA | ||
| Z-0519-03 | Baxter Microbore 3-Lead Extension Set with 0.22 Micron High Pressure Pediatric Filter... | Baxter Healthcare Corporation | FPA |