The Recall Desk

Hazard

Regulatory Compliance recalls

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

What the numbers show

Total
22
Critical
0
Severe
5
Most recent
2020-11-25

Of the 22 regulatory compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (23%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all regulatory compliance 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.

1–22 of 22

  • HighFDA (Devices)·Z-0449-2021·2020-11-25

    Thomas Scientific Recalls Wuxi Nest Patient Specimen Collection Tubes

    Thomas Scientific is recalling Wuxi Nest patient specimen collection tubes to replace units manufactured and distributed prior to Enforcement Discretion Approval.

    Product
    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0236-2020·2019-11-06

    Mindray Accutorr 7 Vital Signs Monitor Software Recall

    Mindray is recalling 107 Accutorr 7 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2019·2018-12-26

    COVIDIEN Recalls 8Fr Argyle Suction Catheter Kits with Chimney Valve

    COVIDIEN LLC is recalling 32,071 units of 8Fr Argyle Suction Catheter Kits with Chimney Valve, Model 36826, because they were distributed while subject to importation refusal.

    Product
    8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0487-2019·2018-11-28

    FDA Mandates Recall of PremierPro Aluminum Adjustable Walkers

    SVS LLC is recalling 256 PremierPro Aluminum Adjustable Walkers due to an FDA order for stock recovery and return of imported items.

    Product
    PremierPro Aluminum Adjustable Walker
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-1172-2018·2018-05-09

    Riddhi USA Inc. Recalls All Dietary Supplements Under Consent Decree

    Riddhi USA Inc. is recalling all dietary supplements it manufactures and distributes in New York, Delaware, and New Jersey pursuant to a Consent Decree.

    Product
    All dietary supplements manufactured and distributed by Riddhi USA Inc.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1062-2017·2017-01-04

    Sunset Natural Products Recalls Chinen Dietary Supplement Under Consent Decree

    Sunset Natural Products Inc. is recalling Chinen Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 2014.

    Product
    Chinen Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0961-2017·2017-01-04

    Sunset Natural Products Recalls Prostaliv New Dietary Supplement

    Sunset Natural Products Inc. is recalling Prostaliv New dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Prostaliv New, 60 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0932-2017·2017-01-04

    Sunset Natural Products Recalls Liver Energy Dietary Supplement

    Sunset Natural Products Inc. is recalling Liver Energy dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Liver Energy, 100 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1059-2017·2017-01-04

    Sunset Natural Products Recalls Libene Dietary Supplement Under Consent Decree

    Sunset Natural Products Inc. is recalling Libene Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2014.

    Product
    Libene Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1902-2016·2016-06-08

    Exactech Recalls Four Novation Femoral Stems Due to Premature Packaging

    Exactech is recalling four Novation femoral stems because they were packaged before the required site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0539-2015·2014-12-17

    Instrumed Recalls Manual Trephines for Regulatory Compliance

    Instrumed International is withdrawing 74 manual trephines from the market because the devices do not meet FDA requirements for pre-amendment marketing.

    Product
    Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0549-2015·2014-12-17

    Instrumed Recalls Galt Trephines for Regulatory Compliance Issues

    Instrumed International is withdrawing Galt trephines because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0552-2015·2014-12-17

    Instrumed Recalls Lock Nuts for Titanium Traction Tongs

    Instrumed International is withdrawing 49 lock nuts for titanium traction tongs because the devices were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.

    Product
    Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0553-2015·2014-12-17

    Instrumed Recalls Titanium Fixation Screws for Regulatory Compliance Issues

    Instrumed International is withdrawing 22 springloaded titanium fixation screws from the market because the devices were not marketed prior to 1976 and do not meet FDA pre-amendment requirements.

    Product
    Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand name
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0554-2015·2014-12-17

    Instrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance

    Instrumed International is withdrawing 17 traction tong replacement screws because they do not meet FDA requirements for pre-amendment devices.

    Product
    Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0903-2014·2014-02-12

    Stryker Neptune 2 Rover Ultra Waste Management System Field Upgrade

    Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.

    Product
    Neptune 2 Rover Ultra Waste Management System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2012·2012-07-25

    GE Healthcare Recalls Optima Mobile X-ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR200 and XR220 mobile X-ray systems because a software issue affects the visual indication required by regulations.

    Product
    GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
    Category
    Medical Device
    Distribution
    Distributed nationwide