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-0597-03 | Intellivue Information Center Model: M3150BU#CO1 | Philips North America LLC | |||
| Z-0596-03 | Intellivue Information Center Model: M3150B#C01 | Philips North America LLC | |||
| Z-0595-03 | Viridia/Agilent Information Center Model : M3151A#CO1 | Philips North America LLC | |||
| Z-0594-03 | Viridia/Agilent Information Center Model : M3150A#C01 | Philips North America LLC | |||
| Z-0671-03 | Permobil Chairman 2K powered wheelchair, Model 1280 | Permobil, AB | I--TI | ||
| Z-0573-03 | Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder... | Dynarex Corp. | FXX | ||
| Z-0572-03 | Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in... | Dynarex Corp. | FXX | ||
| Z-0669-03 | LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645 | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0569-03 | Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution... | Ortho Development Corp. | |||
| Z-0568-03 | Hip Prosthesis as a component of Primaloc Cemented Hip System. | Ortho Development Corp. | |||
| Z-0567-03 | Hip Prosthesis as a component of Primaloc Cementless/Collarless Hip System | Ortho Development Corp. | |||
| Z-0566-03 | Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System. | Ortho Development Corp. | |||
| Z-0465-03 | Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per... | Meridian Bioscience Inc | LYR | ||
| Z-0464-03 | Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per... | Meridian Bioscience Inc | MCB | ||
| Z-0463-03 | Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per... | Meridian Bioscience Inc | MCB | ||
| Z-0628-03 | BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc... | bioMerieux, Inc. | GJS | ||
| Z-0565-03 | HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare... | Baxter Healthcare Corporation | FKX | ||
| Z-0564-03 | HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare... | Baxter Healthcare Corporation | FKX | ||
| Z-1081-04 | STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin... | Diagnostica Stago, Inc. | JOX | ||
| Z-0492-03 | Misys Laboratory version 5.3 | CliniSys, Inc | JQP | ||
| Z-0495-03 | Misys Laboratory, GUI version 5.3 | CliniSys, Inc | JQP | ||
| Z-0469-03 | Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use... | Megadyne Medical Products, Inc | GEI | ||
| Z-0468-03 | Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE | Megadyne Medical Products, Inc | GEI | ||
| Z-0525-03 | Pulmonary heart valve allograft, human tissue for transplantation. | Lifenet | MIE | ||
| Z-0557-03 | CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896... | Ortho-Clinical Diagnostics, Inc. | |||
| Z-0453-03 | Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set... | Baxter Healthcare Corporation | KSB | ||
| Z-0452-03 | Y-Type Blood/Solution Set with Pressure Pump, catalog #1C8658; Standard Blood Filter (170... | Baxter Healthcare Corporation | KSB | ||
| Z-0451-03 | Y-Type Blood/Solution Set, catalog #1C8459; Standard Blood Filter (170 to 260 micron)... | Baxter Healthcare Corporation | KSB | ||
| Z-0450-03 | Y-Type Blood/Solution Set, catalog #1C8372; Standard Blood Filter (170 to 260 micron)... | Baxter Healthcare Corporation | KSB | ||
| Z-0449-03 | Y-Type Blood/Solution Set, catalog #1C8117; Standard Blood Filter (170 to 260 micron)... | Baxter Healthcare Corporation | KSB | ||
| Z-0448-03 | Y-Type Blood/Solution Set, catalog #1C8029; Standard Blood Filter (170 to 260 micron)... | Baxter Healthcare Corporation | KSB | ||
| Z-0421-03 | AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03 | Abbott Medical | JJE | ||
| Z-0503-03 | Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number... | Haemonetics Corporation | CAC | ||
| Z-0502-03 | Haemonetics Cell Saver 5 Low Volume (125mL) Fast Pack List Number: 265 | Haemonetics Corporation | CAC | ||
| Z-0501-03 | Haemonetics High Speed Cell Saver Bowl Set List Number: 263 | Haemonetics Corporation | CAC | ||
| Z-0500-03 | Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261 | Haemonetics Corporation | CAC | ||
| Z-0499-03 | Haemonetics Cell Saver 5 Fast Pack with Filtered Reservoir List Number: 260F | Haemonetics Corporation | CAC | ||
| Z-0498-03 | Haemonetics Cell Saver 5 Fast Pack List Number: 260 | Haemonetics Corporation | CAC | ||
| Z-0548-03 | Zoll AED Plus Defibrillator (Automatic External Defibrillator) | ZOLL Medical Corporation | MKJ | ||
| Z-0055-06 | Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020... | OriGen Biomedical, Inc. | DQO | ||
| Z-0545-03 | SYNCHRON LX20 AND LX20 Pro | Siemens Healthcare Diagnostics Inc. | JGS | ||
| Z-0446-03 | Bed/chair alarm | RF Technologies, Inc. | KMI | ||
| Z-0491-03 | Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108 | Abbott Medical | DSQ | ||
| Z-0606-03 | External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences... | Integra LifeSciences Corporation | LID | ||
| Z-0405-03 | FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot... | Alcon Laboratories | LPM | ||
| Z-0438-03 | PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734. | Roche Diagnostics GmbH | |||
| Z-0685-03 | Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos... | EMD Millipore Corporation | HZJ | ||
| Z-0684-03 | Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule... | EMD Millipore Corporation | LCH | ||
| Z-0627-03 | AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories... | Abbott Diagnostic International, Ltd. | JJE | ||
| Z-0683-03 | Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule... | EMD Millipore Corporation | LCH |