Medical DeviceSep 9, 2015
Arrow International, Inc recall — FDA Z-2489-2015
saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.
Class IIFDA: TerminatedArrow International Inc.
29,963medical device recall records
2,598FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1156
29,963 detailed records are currently available in this category.
Medical DeviceSep 9, 2015
Customed D & C LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2589-2015
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, 12 F, T-Piece (Product Code 2155) recall — FDA Z-2492-2015
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 GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS Used by medical staff to perform recall — FDA Z-2619-2015
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
Beckman Coulter COULTER ISOTON 4 Diluent, Catalog No. 8547148 recall — FDA Z-2481-2015
Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceSep 9, 2015
Customed PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient recall — FDA Z-2716-2015
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* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F recall — FDA Z-2519-2015
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 L/F 5/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2714-2015
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 NEURO PACK 3/CS Used by medical staff to perform surgical procedures and patient recall — FDA Z-2568-2015
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 UROLOGY SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2637-2015
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
Roche Molecular Systems cobas Liat Analyzer, for in vitro diagnostic use recall — FDA Z-2543-2015
Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.
Class IIFDA: TerminatedRoche Molecular Systems, Inc.
Medical DeviceSep 9, 2015
Covidien Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety recall — FDA Z-2534-2015
Sterility may be compromised
Class IIFDA: TerminatedCovidien LLC
Medical DeviceSep 9, 2015
Bayer Healthcare Contour Next Control Solution for Contour Next Blood Glucose Test System recall — FDA Z-2482-2015
If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by…
Class IIFDA: TerminatedBayer Healthcare, LLC
Medical DeviceSep 9, 2015
Customed UNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS Used by medical staff to perform surgical recall — FDA Z-2553-2015
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* Multi-Access Port Closed Suction System for Adults,Tracheostomy recall — FDA Z-2518-2015
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 O.B. PACK 5/CS Used by medical staff to perform surgical procedures and patient recall — FDA Z-2641-2015
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 MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and recall — FDA Z-2606-2015
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 REEMPLAZO DE RODILLA Y CADERA 2/CS Used by medical staff to perform surgical recall — FDA Z-2653-2015
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 FOLEY CATHETER KIT II 16FR recall — FDA Z-2566-2015
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-2532-2015
Sterility may be compromised
Class IIFDA: TerminatedCovidien LLC
Medical DeviceSep 9, 2015
Customed PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2711-2015
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 TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2665-2015
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, Straight Extensions with IC* Safety recall — FDA Z-2530-2015
Sterility may be compromised
Class IIFDA: TerminatedCovidien LLC
Medical DeviceSep 9, 2015
Customed ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and recall — FDA Z-2709-2015
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.