Medical DeviceSep 9, 2015
Covidien MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight recall — FDA Z-2537-2015
Sterility may be compromised
Class IIFDA: TerminatedCovidien LLC
29,963medical device recall records
2,598FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1155
29,963 detailed records are currently available in this category.
Medical DeviceSep 9, 2015
Customed LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2570-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2693-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Intuitive Surgical da Vinci Xi Surgical System P4 software;with Xi Stapler recall — FDA Z-2734-2015
Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceSep 9, 2015
Customed OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2614-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed SURGICAL PACK 20/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2627-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow recall — FDA Z-2728-2015
Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the…
Class IIFDA: TerminatedTransonic Systems Inc.
Medical DeviceSep 9, 2015
Customed HIGADO Y PANCREA 2/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2616-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Philips Medical Systems (Cleveland) Ingenuity TF PET/MR, Diagnostic Imaging System , Philips recall — FDA Z-2491-2015
Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceSep 9, 2015
Customed MAJOR LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2554-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed WOUND MANAGEMENT TRAY II 30/CS Used by medical staff to perform surgical procedures recall — FDA Z-2573-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed CARPAL TUNEL LARGE SURGICAL PACK, 6/CS Used by medical staff to perform surgical recall — FDA Z-2701-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2612-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed LAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures and recall — FDA Z-2574-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Halyard Health KimVent* Closed Suction System for Adults, 14 F, DSE, MDI recall — FDA Z-2508-2015
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.
Class IIFDA: TerminatedHalyard Health, Inc.
Medical DeviceSep 9, 2015
Customed OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2649-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) Used by medical staff to perform recall — FDA Z-2685-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient recall — FDA Z-2562-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient recall — FDA Z-2710-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Customed O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and recall — FDA Z-2604-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Halyard Health KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in recall — FDA Z-2499-2015
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.
Class IIFDA: TerminatedHalyard Health, Inc.
Medical DeviceSep 9, 2015
Customed ARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedures and recall — FDA Z-2563-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
Medical DeviceSep 9, 2015
Covidien Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety recall — FDA Z-2531-2015
Sterility may be compromised
Class IIFDA: TerminatedCovidien LLC
Medical DeviceSep 9, 2015
Customed CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient recall — FDA Z-2672-2015
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class IIFDA: TerminatedCustomed, Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.