The Recall Desk

Hazard

Leak Test Failure recalls

11 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
11
Critical
0
Severe
0
Most recent
2019-08-14

Of the 11 leak test failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all leak test failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–11 of 11

  • HighFDA (Devices)·Z-2137-2019·2019-08-14

    MED-EL SONATAti100 Cochlear Implant Recall for Leak Test Failures

    MED-EL is recalling 10 SONATAti100 cochlear implants because they failed helium-fine leak tests. The devices were distributed despite not meeting specifications.

    Product
    MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2019·2019-08-14

    MED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures

    MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.

    Product
    MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2018·2018-01-17

    Ambu Universal Flex2 Breathing Circuits Recalled for Leak Test Failures

    King Systems Corp. dba Ambu, Inc. is recalling 871,116 Universal Flex2 Breathing Circuits due to potential leak test failures.

    Product
    UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0741-2017·2016-12-21

    Cypress Medical Recalls McKesson Vinyl Exam Gloves for Leak Test Failure

    Cypress Medical Products is recalling McKesson Powder Free Vinyl Exam Gloves because a container failed the FDA leak test. The recall is limited to one distribution center in Auburn, Washington.

    Product
    McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2245-2014·2014-08-27

    Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failure

    Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed a leak test due to damage of the inner cavity.

    Product
    Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2248-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Screws because they failed a leak test due to damage of the inner cavity.

    Product
    6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2251-2014·2014-08-27

    Zimmer Recalls 4.0 mm Cancellous Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 4.0 mm Cancellous Screws because they failed leak tests due to inner cavity damage.

    Product
    4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2247-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Trauma Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Trauma Screws because they failed leak tests due to inner cavity damage.

    Product
    6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2244-2014·2014-08-27

    Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed leak tests due to inner cavity damage.

    Product
    Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2250-2014·2014-08-27

    Zimmer Recalls 4.5 mm Malleolar Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws because they failed a leak test due to inner cavity damage.

    Product
    4.5 mm Malleolar Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2249-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.

    Product
    6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states