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

15326–15350 of 27762

HighFDA (Devices)·Z-0385-2024·2023-11-29
Biomet Compress Device Short Anchor Plug Recalled Due to Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (23 MM) due to potential metal burrs in transverse holes that may prevent proper insertion of surgical instruments, potentially extending surgery time. Distribution includes US and multiple international countries.
Product
Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2024·2023-11-29
Compress Device Anchor Plugs recalled due to metal burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drill or pins from passing through, potentially extending surgical time.
Product
Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0389-2024·2023-11-29
Philips Achieva 1.5T MRI systems recalled for potential gradient coil fire risk
Philips is recalling Achieva 1.5T MRI systems due to potential gradient coil failure that could produce smoke and/or fire. Approximately 520 units have been distributed nationwide and internationally.
Product
Achieva 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0360-2024·2023-11-29
Avanos BALLARD Closed Suction System mislabeled for DEHP content
Certain lots of AVANOS BALLARD Closed Suction System for Adults were labeled as DEHP-free but contain DEHP in tubing components. These units are used for mechanical ventilation and distributed in the US and South Africa.
Product
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0329-2024·2023-11-29
Colonoscopes Recalled for Unvalidated Channel Drying Process and Infection Risk
Aizu Olympus is recalling certain colonoscope models because the channel air drying process was not validated. A small percentage of repaired units had water remaining in the channel, which could lead to infection risk.
Product
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0342-2024·2023-11-29
Sigmoidovideoscope models recalled due to improper channel drying process
Aizu Olympus sigmoidovideoscope (model PCF-S) units are being recalled due to an unvalidated channel drying process. Some repaired units returned with water in channels, risking contamination and infection.
Product
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0337-2024·2023-11-29
Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk
Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.
Product
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0362-2024·2023-11-29
BreathTech Manual Resuscitators Recalled for Integrated Manometer Leak
SunMed Holdings is recalling BreathTech manual resuscitators because the integrated manometer can leak, allowing patients to rebreathe exhaled CO2 during emergency airway management.
Product
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant Res
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2024·2023-11-29
Hysterovideoscope Models Recalled Due to Improper Channel Drying Risk
Aizu Olympus is recalling Hysterovideoscope Model HYF-V units (27 devices) because the channel air drying process was not validated. Water remaining in device channels could pose an infection risk.
Product
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0465-2024·2023-11-29
Jeni's Splendid Ice Cream Recalled for Aluminum and Steel Contamination
Jeni's Splendid Ice Cream Buttercream Birthday Cake is recalled for potential aluminum and stainless steel pieces in the product. Consumers should stop consuming and return all affected packages.
Product
Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard pint cups with heat seals and paper lids - 8 pints per case
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0320-2024·2023-11-29
Medtronic Mo.Ma Ultra cerebral protection device labeling error recalled
Medtronic is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to labeling errors on the manifold that result in incorrect identification of inflation and deflation ports.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0375-2024·2023-11-29
Biomet Compress Device Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent proper device function during surgery. The defect could result in extended surgical time.
Product
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0113-2024·2023-11-29
Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk
FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0398-2024·2023-11-29
Robotic patient positioning system may move unexpectedly after interruption
The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.
Product
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2024·2023-11-29
Gastroscope Devices Recalled for Inadequate Channel Drying Process
Aizu Olympus recalls 680 gastroscope-EUS devices due to unvalidated channel drying. Water remaining in the channels poses contamination and infection risks.
Product
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0377-2024·2023-11-29
Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly
Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.
Product
Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0358-2024·2023-11-29
Blood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors
The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.
Product
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0399-2024·2023-11-29
ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk
The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.
Product
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0322-2024·2023-11-29
Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled
Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2024·2023-11-29
Alinity c Iron Reagent Recalled for Falsely Elevated Test Results
The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.
Product
Alinity c Iron Reagent, Reference Number 08P3920
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0386-2024·2023-11-29
Surgical implant anchor plugs may contain metal burrs affecting insertion
Biomet's Compress Device Short Anchor Plugs may contain metal burrs in the transverse holes, which can prevent proper insertion of surgical tools and extend surgery time. The affected devices are distributed nationwide and internationally.
Product
Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0111-2024·2023-11-29
Hand Sanitizer Recalled for Excess Acetal and Acetaldehyde Contamination
Integrity Biochem hand sanitizer recalled due to contamination with acetal and acetaldehyde at levels above FDA standards. The product was distributed to one Oklahoma distributor.
Product
Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0325-2024·2023-11-29
IRON assay kits recalled for inaccurate diagnostic results
Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.
Product
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0384-2024·2023-11-29
Compress Device Short Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.
Product
Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0356-2024·2023-11-29
Stryker Sage PrimaFit Female Urine Management Systems recalled for undeclared latex adhesive
Sage Products is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems in three lots because a small percentage may contain tape with undeclared natural rubber latex adhesive.
Product
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Category
Medical Device
Distribution
0 states

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15326–15350 of 27762