Medical DeviceJul 29, 2015
Covidien Major Kit, Sterile-.Kits containing the Devon Light Glove recall — FDA Z-2114-2015
Devon Light Gloves contain splits or holes compromising the sterility
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 1172
29,963 detailed records are currently available in this category.
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center 365¿M Lithotripsy Fiber- Reusable recall — FDA Z-2163-2015
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper…
Class IIFDA: TerminatedAmerican Medical Systems Innovation Center - Silicon…
Medical DeviceJul 29, 2015
Cook Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular recall — FDA Z-2100-2015
Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
Class IIFDA: TerminatedCook Inc.
Medical DeviceJul 29, 2015
DePuy Orthopaedics ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial recall — FDA Z-2142-2015
Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and…
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJul 29, 2015
Allergan Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue recall — FDA Z-2103-2015
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Class IIFDA: TerminatedAllergan Inc.
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center Fiber Stripper, 365¿m, Autoclavable recall — FDA Z-2167-2015
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper…
Class IIFDA: TerminatedAmerican Medical Systems Innovation Center - Silicon…
Medical DeviceJul 29, 2015
Perkinelmer Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The recall — FDA Z-2124-2015
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Class IIFDA: TerminatedPerkinelmer
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center 1X1 Cleaving Tiles recall — FDA Z-2171-2015
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper…
Class IIFDA: TerminatedAmerican Medical Systems Innovation Center - Silicon…
Medical DeviceJul 29, 2015
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to recall — FDA Z-2208-2015
Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient…
Class IIFDA: TerminatedSilhouette Lift, Inc.
Medical DeviceJul 29, 2015
Philips Medical Systems (Cleveland) GEMINI GXL 16 Slice CT/PET System recall — FDA Z-2193-2015
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceJul 29, 2015
Philips Medical Systems (Cleveland) Head Holder shipped with Ingenuity CT Computed recall — FDA Z-2205-2015
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceJul 29, 2015
Allergan Natrelle CUI Series Tissue Expanders recall — FDA Z-2104-2015
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
Class IIFDA: TerminatedAllergan Inc.
Medical DeviceJul 29, 2015
Myoscience iovera 155 Smart Tip recall — FDA Z-2201-2015
The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were…
Class IIFDA: TerminatedMyoscience Inc.
Medical DeviceJul 29, 2015
Perkinelmer Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200 recall — FDA Z-2129-2015
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Class IIFDA: TerminatedPerkinelmer
Medical DeviceJul 29, 2015
GE Healthcare Precision RXi 23A/32A Analog System recall — FDA Z-2121-2015
A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor…
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJul 29, 2015
Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy recall — FDA Z-2190-2015
Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.
Class IIFDA: TerminatedMermaid Medical A/S
Medical DeviceJul 29, 2015
Cook Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended recall — FDA Z-2101-2015
Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
Class IIFDA: TerminatedCook Inc.
Medical DeviceJul 29, 2015
DePuy Orthopaedics ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial recall — FDA Z-2141-2015
Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and…
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJul 29, 2015
DePuy Orthopaedics ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial recall — FDA Z-2139-2015
Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and…
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJul 29, 2015
DePuy Orthopaedics ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation recall — FDA Z-2146-2015
Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and…
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center Sureflex 910 Lithotripsy Fiber, 5x, Blue recall — FDA Z-2161-2015
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper…
Class IIFDA: TerminatedAmerican Medical Systems Innovation Center - Silicon…
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center Tool, Stripper W/BLD, 14S, Autoclavable recall — FDA Z-2177-2015
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper…
Class IIFDA: TerminatedAmerican Medical Systems Innovation Center - Silicon…
Medical DeviceJul 29, 2015
Covidien Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO recall — FDA Z-2119-2015
Devon Light Gloves contain splits or holes compromising the sterility
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 29, 2015
Covidien Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog recall — FDA Z-2108-2015
Devon Light Gloves contain splits or holes compromising the sterility
Class IIFDA: TerminatedCovidien LLC
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.