Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

13326–13350 of 13837

ModerateFDA (Devices)·Z-2215-2021·2021-08-18
Support Surface Device Distributed to Home Patients Without Healthcare Professional Instructions
An Isolibrium Support Surface intended for healthcare facilities was distributed to home customers. While the labeling is correct, home users may not understand instructions intended for healthcare professionals.
Product
Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2210-2021·2021-08-18
InTouch 2131 Medical Device Recalled for Distribution to Residential Users
Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.
Product
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2186-2021·2021-08-11
Abbott Activated Alanine Aminotransferase Reagent Accuracy Issue Recall
Abbott's A-ALT laboratory reagent may produce inaccurate results in samples with very high enzyme levels or elevated bilirubin, potentially affecting patient diagnoses. The affected product (REF 8L92-21) was distributed worldwide.
Product
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2169-2021·2021-08-11
Regard Newborn Heel Warmer Kit Recalled for Inadequate Safety Instructions
ROi CPS LLC is recalling the Regard NEWBORN KIT heel warmer (976 units in Missouri) due to incomplete safety instructions. Updated instructions now warn users to activate the device away from the infant's face and others.
Product
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2167-2021·2021-08-11
Newborn Heel Warmer Kit Instructions Updated for Activation Safety
The Regard Newborn Kit heel warmer is being recalled. Updated instructions now require that the device be activated away from the user's face and away from the infant and others.
Product
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2175-2021·2021-08-11
Fertility IUI Device Recalled for Missing FDA Marketing Authorization
Tenderneeds Fertility LLC is recalling the Flex IUI Set with LED Lighted Speculum due to distribution without FDA marketing authorization. All units sold worldwide prior to December 9, 2019 are affected.
Product
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2201-2021·2021-08-11
In Vitro Diagnostic Reagent Recalled for Reagent Stability Deterioration
Stanbio Laboratory is recalling Synchron Beta-Hydroxybutyrate diagnostic reagent due to reagent deterioration causing quality control values to fall out of expected range.
Product
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2182-2021·2021-08-11
IntraCervical Insemination Kit Recalled for Lack of FDA Marketing Authorization
Tenderneeds Fertility LLC recalled its Deluxe IntraCervical Insemination Kit worldwide because the device was distributed without FDA marketing authorization. The device was sold prior to December 9, 2019.
Product
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2170-2021·2021-08-11
Stryker Nail Insertion Sleeve Recalled for Incorrect Inner Diameter
Stryker is recalling Nail Insertion Sleeves with incorrect inner diameters that do not match the box label. The dimensional mismatch could affect proper fit during orthopedic surgical procedures.
Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2184-2021·2021-08-11
Abbott Alinity c Reagent Kit Recall Due to Potential Test Result Errors
Abbott Laboratories is recalling its Alinity c Activated Alanine Aminotransferase reagent kit due to potential analytical errors that could produce incorrect test results. The issue affects certain lot numbers distributed worldwide.
Product
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2021·2021-08-11
Abbott Activated Alanine Aminotransferase Reagent May Produce Inaccurate Patient Results
Abbott's A-ALT diagnostic reagent may produce inaccurate test results for samples with elevated enzyme or bilirubin levels, potentially affecting patient outcomes. The affected reagent kits have been distributed worldwide.
Product
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2021·2021-08-11
TenderNeeds IUI Fertility Kits Distributed Without FDA Marketing Authorization
TenderNeeds Fertility PRO IUI home insemination kits were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019, are affected.
Product
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2183-2021·2021-08-11
Artificial insemination kits recalled for lack of FDA authorization
Tenderneeds Fertility LLC is recalling artificial insemination kits that were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019 are affected.
Product
2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2198-2021·2021-08-11
Straumann SCS Screwdriver Recalled for Incorrect Tip Configuration
Straumann USA LLC is recalling 130 units of the Straumann SCS Screwdriver (Article 046.401) due to an incorrect tip configuration that prevents proper engagement with screw heads during dental surgery, creating a potential injury risk.
Product
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2176-2021·2021-08-11
Home Artificial Insemination Kit Recalled for Lack of Marketing Authorization
Tenderneeds Fertility LLC is recalling home artificial insemination kits that were distributed without proper FDA authorization. The device was sold worldwide prior to December 9, 2019.
Product
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2171-2021·2021-08-11
Stryker Nail Insertion Sleeve Recalled for Inner Diameter Mismatch
Stryker GmbH is recalling 242 Nail Insertion Sleeves (Catalog Number 18061406S, Lot K03CC4F) because the inner diameter does not match the dimension specified on the outer box label.
Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2178-2021·2021-08-11
Medical Device Recall: Unauthorized Fertility Insemination Kit
All lots of the Ultimate Fertility At Home Insemination Kit sold before December 9, 2019 are recalled. The device was distributed without FDA marketing authorization.
Product
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2179-2021·2021-08-11
Sterile Home Artificial Insemination Kits Recalled for Missing FDA Marketing Authorization
Tenderneeds Fertility LLC is recalling sterile home artificial insemination semen kits distributed worldwide prior to December 9, 2019, due to lack of required FDA marketing authorization.
Product
2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2185-2021·2021-08-11
Abbott Activated Alanine Aminotransferase Reagent Recalled for Inaccurate Test Results
Abbott is recalling 1,603 units of its Activated Alanine Aminotransferase (A-ALT) lab reagent due to potential inaccuracies in test results. High bilirubin or high A-ALT samples may produce incorrect results affecting patient care.
Product
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2021·2021-08-11
AMIA Automated Peritoneal Dialysis System User Guide Contains Incorrect Operating Instructions
The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.
Product
Kaguya Automated Peritoneal Dialysis System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2172-2021·2021-08-11
GlideScope Go Video Monitors Recalled for Waterproof Rating Defect
Verathon recalls GlideScope Go Monitors due to failure to meet IP67 waterproof rating, which may allow fluid ingress and loss of functionality.
Product
GlideScope Go Monitors
Category
Medical Device
Distribution
51 states
ModerateFDA (Devices)·Z-2181-2021·2021-08-11
Deluxe At-Home ICI Insemination Kit Recalled for Unauthorized Distribution
Tenderneeds Fertility LLC recalls its Deluxe At-Home ICI Insemination Kit (SKU 636391205856), all lots sold before December 9, 2019, due to distribution without FDA marketing authorization.
Product
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2173-2021·2021-08-11
Amia Automated PD System User Guide Incorrectly Describes Ultrafiltration Limit Function
Baxter's user guide for the Amia Automated PD System incorrectly describes how the Ultrafiltration Limit setting controls the Extra Last Drain Mode. This documentation error could affect patients' ability to properly end therapy sessions.
Product
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2202-2021·2021-08-11
Beta-Hydroxybutyrate diagnostic reagent recalled due to stability degradation
Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents due to reagent instability causing out-of-range quality control values that may affect diagnostic accuracy.
Product
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2199-2021·2021-08-11
Diagnostic Reagent Stability Issues Lead to Out-of-Range Quality Control Values
Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagent due to reagent deterioration that causes lower than expected or out-of-range quality control values, affecting test accuracy.
Product
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Category
Medical Device
Distribution
Distributed nationwide

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13326–13350 of 13837