Medical DeviceJul 29, 2015
Covidien Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog recall — FDA Z-2112-2015
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 1173
29,963 detailed records are currently available in this category.
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center Sureflex 550 Lithotripsy Fiber, 5x, Blue recall — FDA Z-2160-2015
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, 12S, Nonautoclavable recall — FDA Z-2174-2015
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
Biomet Spine Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial recall — FDA Z-2152-2015
Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
Class IIFDA: TerminatedBiomet Spine, LLC
Medical DeviceJul 29, 2015
Covidien Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog recall — FDA Z-2107-2015
Devon Light Gloves contain splits or holes compromising the sterility
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center Tool, Stripper W/BLD, 18S, Autoclavable recall — FDA Z-2179-2015
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
GE Healthcare Precision RXi Digital system recall — FDA Z-2122-2015
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
DePuy Orthopaedics ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation recall — FDA Z-2144-2015
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 Stripper, 0.6mm Disposable EndoStat Fiber, The recall — FDA Z-2184-2015
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 Stripper, 0.3mm Disposable EndoStat Fiber, The recall — FDA Z-2186-2015
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 Fiber Stripper, 273¿m, Autoclavable recall — FDA Z-2166-2015
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" Reusable Fibers and the Reusable…
Class IIFDA: TerminatedAmerican Medical Systems Innovation Center - Silicon…
Medical DeviceJul 29, 2015
DePuy Orthopaedics ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE recall — FDA Z-2140-2015
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
Perkinelmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma recall — FDA Z-2125-2015
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Class IIFDA: TerminatedPerkinelmer
Medical DeviceJul 29, 2015
Covidien NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile recall — FDA Z-2117-2015
Devon Light Gloves contain splits or holes compromising the sterility
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center Tool, Stripper W/BLD, 28S, Nonautoclavable recall — FDA Z-2182-2015
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 Fiber Stripper, 910¿m, Autoclavable recall — FDA Z-2169-2015
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
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 recall — FDA Z-2135-2015
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Class IIFDA: TerminatedVolcano Corporation
Medical DeviceJul 29, 2015
Philips Medical Systems (Cleveland) Head Holder shipped with Ingenuity Core 128 Computed recall — FDA Z-2204-2015
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system.
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceJul 29, 2015
Perkinelmer WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" recall — FDA Z-2126-2015
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Class IIFDA: TerminatedPerkinelmer
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center Tool, StripperW/BLD, 10S, Nonautoclavable recall — FDA Z-2172-2015
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 Fiber Stripper, 200¿m, Autoclavable recall — FDA Z-2165-2015
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" Reusable Fibers and the Reusable…
Class IIFDA: TerminatedAmerican Medical Systems Innovation Center - Silicon…
Medical DeviceJul 29, 2015
American Medical Systems Innovation Center Sureflex 200 Lithotripsy Fiber, 5x, Blue recall — FDA Z-2157-2015
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
CooperSurgical Infant Heel Warmer and Infant Gel Warmer, sold under the brand names recall — FDA Z-2147-2015
Product marketed without a 510(k)
Class IIFDA: TerminatedCooperSurgical, Inc.
Medical DeviceJul 29, 2015
DePuy Orthopaedics ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial recall — FDA Z-2145-2015
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.
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.