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 the agency’s own highest classification or reported deaths or serious injuries, 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

126–150 of 40397

HighFDA (Devices)·Z-3295-2026·2026-10-07
Cardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
Cardinal Health is recalling 3,677 Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets because handpieces may leak fluid, creating a slip and fall hazard.
Product
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3304-2026·2026-10-07
Heraeus Medical Recalls PALACOS MV Pro Bone Cement Due to Leakage Risk
Heraeus Medical is recalling PALACOS MV pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall covers all lot numbers distributed worldwide.
Product
PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3277-2026·2026-10-07
United Imaging uCT 530 CT Systems Recalled for Software Visibility Issue
Shanghai United Imaging Healthcare is recalling four uCT 530 CT systems due to a software defect that may hide patient images, potentially requiring rescans.
Product
Computed Tomography X-ray System, Model: uCT 530 with software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3275-2026·2026-10-07
Bard EnCor EnCompass Breast Biopsy System Software Recall
Bard Peripheral Vascular Inc is recalling 99 EnCor EnCompass Breast Biopsy and Tissue Removal Systems due to software errors that may interrupt procedures.
Product
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3305-2026·2026-10-07
Embosphere Microspheres Recalled Due to Packaging Sterility Concerns
Merit Medical Systems is recalling Embosphere microspheres because packaging holes may compromise sterility, posing an infection risk.
Product
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3271-2026·2026-10-07
Alere hCG Pregnancy Test Cassettes Recalled for False Positive Results
Alere San Diego is recalling hCG rapid test cassettes because they may detect low hormone levels, leading to false positive pregnancy results.
Product
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531, FHC-A202/23900530; McKesson CONSULT Diagnostics hCG Urine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3323-2026·2026-10-07
Percussionaire Impulsator and Phasitron 5 Recall for Anesthesia Warning Update
Percussionaire Corporation is recalling Impulsator and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
Product
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3330-2026·2026-10-07
Tandem t:slim iOS App Recall Due to CGM Pairing Failure
Tandem Diabetes Care is recalling a beta version of its t:slim iOS app because it fails to pair with Abbott FreeStyle Libre 3 Plus sensors, forcing users into manual mode.
Product
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3335-2026·2026-10-07
Siemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling Atellica CH Revised C-Reactive Protein reagent due to the potential for falsely elevated test results.
Product
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3289-2026·2026-10-07
FDA Recalls Performance Pro Nitrile Gloves Due to Defects
American Nitrile Operations is recalling Performance Pro blue nitrile gloves due to defects like tears and debris that may expose users to pathogens or chemicals.
Product
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination gloves
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3274-2026·2026-10-07
Alere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
Alere San Diego is recalling multiple hCG urine pregnancy test models because they may detect low hCG levels, resulting in false positive results.
Product
Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217; Cardinal Health hCG Cassette Rapid test…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3306-2026·2026-10-07
NOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
NOXBOX LTD is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems due to a manufacturing issue that may cause irregular oxygen readings.
Product
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3320-2026·2026-10-07
Percussionaire In-Line Valve Recalled for Anesthetic Delivery Warning
Percussionaire Corporation is recalling 98,434 In-Line Valves to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
Product
In-Line Valve, Product Number: P5-TEE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3303-2026·2026-10-07
Heraeus Medical Recalls PALACOS MV+G Pro Bone Cement Due to Leakage
Heraeus Medical is recalling PALACOS MV+G pro 40 and 80 bone cement due to potential monomer liquid leakage. The recall affects 20,523 units distributed worldwide.
Product
PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3334-2026·2026-10-07
Wright Medical Recalls Charlotte Claw Screws Due to Missing Threads
Wright Medical Technology is recalling 34 Charlotte Claw Screws because missing threads on the screwheads may prevent secure engagement with the plate, potentially prolonging surgery.
Product
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3290-2026·2026-10-07
FDA Recalls Defective Blue Nitrile Patient Examination Gloves
American Nitrile Operations LLC is recalling 36.8 million Opportunity Flex blue nitrile gloves due to defects like tears and debris that may expose users to pathogens or chemicals.
Product
Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examination gloves
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3297-2026·2026-10-07
Cardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
Cardinal Health 200, LLC is recalling 2,957 gynecological laparoscopy kits because the handpieces may leak fluid, creating a slip and fall hazard.
Product
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA2; 4) KIT, GYN…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3298-2026·2026-10-07
Cardinal Health Recalls Presource Packs with Leaking Handpieces
Cardinal Health 200, LLC is recalling 22 Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets because the handpieces may leak fluid, creating a slip and fall hazard.
Product
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3292-2026·2026-10-07
FDA Recalls Medical Kits with Contaminated Pericare Wipes
American Contract Systems Inc. is recalling medical convenience kits containing BD CliniClean Pericare Wipes due to potential lubricant contamination.
Product
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3281-2026·2026-10-07
United Imaging uCT ATLAS CT Systems Recalled for Software Defect
Shanghai United Imaging Healthcare is recalling 11 uCT ATLAS CT systems due to a software issue that may hide patient images, potentially requiring rescans.
Product
Computed Tomography X-ray System, Model: uCT ATLAS with software
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0044-2027·2026-10-07
ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling sterile disposable tourniquet cuffs because they are labeled with a 10-year shelf life, while the correct validated shelf life is 5 years.
Product
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2027·2026-10-07
ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling 6,100 units of Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Product
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0064-2027·2026-10-07
Recall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling MPR Single Use Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Product
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Model/Catalog Number: DT-7115-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0022-2027·2026-10-07
ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Date
ASP Global, LLC. is recalling 240 units of Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
Product
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0066-2027·2026-10-07
FDA Recalls MPR Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global, LLC. is recalling MPR Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life, but the validated shelf life is only 5 years.
Product
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or…
Category
Medical Device
Distribution
Distributed nationwide

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126–150 of 40397