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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

30,447medical device recall records

2,766FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1240

30,447 detailed records are currently available in this category.

Medical DeviceDec 10, 2014

Customed Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565 recall — FDA Z-0260-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Cirugia Cardiovascular Case Cart, Catalog number 900-1415A recall — FDA Z-0291-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care recall — FDA Z-0401-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by recall — FDA Z-0360-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform recall — FDA Z-0283-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Breat Pack-TPSC, Catalog number 900-3431 recall — FDA Z-0375-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Ophtalmic Pack, Catalog number 900-1780 recall — FDA Z-0315-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Gown Surgical Fabric Reinforced XL, Catalog number 900-2568 recall — FDA Z-0263-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Cesarean Pack, Catalog number 900-410 recall — FDA Z-0379-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Gown Surg Fully Impervious Large, Catalog number 900-2564 recall — FDA Z-0259-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Laparoscopy Pack, Catalog number 900-028 recall — FDA Z-0267-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient care recall — FDA Z-0415-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Beevers Manufacturing & Supply Cannulaide, Model 101 recall — FDA Z-0487-2015

Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.

Class IIFDA: TerminatedBeevers Manufacturing & Supply, Inc.

Medical DeviceDec 10, 2014

Customed Dressing Change, Catalog number 900-1538 recall — FDA Z-0300-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform recall — FDA Z-0331-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Urology Pack, Catalog number 900-1738 recall — FDA Z-0312-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Cesarean Pack, Catalog number 900-1719 recall — FDA Z-0310-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Pery GYN Surgical Pack, Catalog number 900-548A recall — FDA Z-0388-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used recall — FDA Z-0491-2015

Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceDec 10, 2014

Customed Foley Catheter Kit, Catalog number 900-1127 recall — FDA Z-0276-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care recall — FDA Z-0334-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care recall — FDA Z-0266-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Arthroscopy Pack, Catalog number 900-1062 recall — FDA Z-0274-2015

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and…

Class IFDA: TerminatedCustomed, Inc.

Medical DeviceDec 10, 2014

Customed Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care recall — FDA Z-0332-2015

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions…

Class IFDA: 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.