Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

17626–17650 of 50403

HighFDA (Devices)·Z-0832-2022·2022-04-06
Ambulatory infusion pumps recalled due to erroneous software installation
InfuTronix is recalling Nimbus PainPro ambulatory infusion pumps after an unreleased software version was installed in error. The defective units may impact patient safety.
Product
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V221000·2022-04-06
Prevost Recalls 2010-2023 Buses Due to Alternator Belt Fire Risk
Prevost is recalling 6,342 buses from 2010-2023 because a seizing alternator bearing can overheat and cause a fire. Owners will receive free belt replacements.
Product
PREVOST — PREVOST X3-45 COMMUTER, H3-45 VIP, X3-45, X3-45 VIP
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0851-2022·2022-04-06
Hanger-Bar 2P Medical Device Recalled for Loosening Set Screw
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect allowing the set screw to loosen, creating a fall hazard.
Product
Hanger-Bar 2P 45cm
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22E031000·2022-04-06
Volkswagen Recalls Rear Hatch Spoilers for 2018-2022 Tiguan Vehicles
Volkswagen is recalling rear hatch spoilers for 2018-2022 Tiguan long wheel base vehicles because incorrect installation instructions may cause the spoiler to detach.
Product
STRUCTURE:BODY recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0855-2022·2022-04-06
Medtronic MiniMed insulin pumps may not deliver basal insulin without configuration
Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.
Product
MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS…
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-0849-2022·2022-04-06
Radiation therapy planning software: incorrect dose density calculation
RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.
Product
RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0914-2022·2022-04-06
Carbquik Cinnamon Spice Mug Cakes recalled for undeclared milk allergen
Carbquik Cinnamon Spice Mug Cakes contain undeclared milk allergen. Approximately 1,700 cases distributed through an Amazon distribution center in New Mexico are affected. Consumers with milk allergies should not consume this product.
Product
Carbquik Mug Cakes Cinnamon Spice, Net Wt. 9 oz 1.5oz mug cake mix packaged in foil pouch 6 servings per pouch, 24 pouches per case
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0731-2022·2022-04-06
Testosterone Cypionate/Anastrozole Injectable Recalled for Sterility Assurance Defect
APS Pharmacy is recalling 73 vials of Testosterone Cypionate/Anastrozole oil due to lack of sterility assurance. The product was distributed nationwide including Puerto Rico.
Product
TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0843-2022·2022-04-06
Hip prosthetic femoral head component size and offset labeling mismatch
Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.
Product
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V226000·2022-04-06
2022 Volkswagen Tiguan rear spoiler risks detaching from vehicle
2022 Volkswagen Tiguan vehicles are recalled due to insufficient attachment of the rear hatch spoiler. The spoiler may separate from the vehicle, creating a road hazard and increasing crash risk.
Product
VOLKSWAGEN — VOLKSWAGEN TIGUAN
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V222000·2022-04-06
Volvo Bus Recalls 2020 9700 DOT Vehicles Due to Fire Risk
Volvo Bus is recalling 48 2020 9700 DOT vehicles because a seizing alternator bearing can overheat and cause a fire. Owners will receive replacement belts free of charge.
Product
VOLVO BUS — VOLVO BUS 9700
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0735-2022·2022-04-06
Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Drug Depot recalled 17 vials of Testosterone Cypionate Injectable due to lack of sterility assurance in manufacturing. The recalled product was distributed nationwide and should not be used.
Product
TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0830-2022·2022-04-06
Siemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors
Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.
Product
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0847-2022·2022-04-06
BALLARD Multi-Access Port Catheter Recalled for Incorrect Expiration Date
Avanos Medical is recalling 2,520 BALLARD Multi-Access Port Catheters due to incorrect expiration dates on the packaging. No illnesses or injuries have been reported. Patients should verify the lot number and contact their healthcare provider.
Product
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0736-2022·2022-04-06
Glycopyrrolate Tablets Recalled Due to Glass Pieces in Sealed Bottles
Aurolife Pharma is recalling Glycopyrrolate Tablets after glass fragments were discovered in a sealed bottle from packaging equipment. Approximately 4,080 bottles were distributed nationwide and in Puerto Rico.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0835-2022·2022-04-06
Tissue oximeter module may provide inaccurately low oxygen readings
Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.
Product
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0960-2022·2022-04-06
Good & Gather Dried Strawberries Recalled for Undeclared Sulfites
Good & Gather Dried Sweetened Strawberries are being recalled due to undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.
Product
Good & Gather Dried Sweetened Strawberries. Net Wt 4 oz (113g). UPC 085239-182840 No Sulfites Added. No Artificial Flavors. No Synthetic Colors. Distributed by Target Corporation, Minneapolis, MN 55403
Category
Food
Distribution
20 states
HighFDA (Food)·F-0916-2022·2022-04-06
Carbquik Complete Biscuit Mix Recalled for Undeclared Milk Allergen
Tova Industries Inc is recalling Carbquik Complete Biscuit and Baking Mix due to undeclared milk allergen. The recall affects 224 cases distributed through an Amazon distribution center in New Mexico.
Product
Carbquik Complete Biscuit and Baking Mix, Net Wt. 3lb *Contained 1 free sample of Cinnamon Spice Mug Cake
Category
Food
Distribution
1 state
HighFDA (Food)·F-0917-2022·2022-04-06
Tam's Homemade Biscuits recalled for missing allergen and ingredient labels
Tam's Homemade Biscuits (Batch No. 015-022) are recalled due to missing allergen statement and ingredient list. Consumers with food allergies cannot identify potential allergens in the product.
Product
Tam's Homemade Biscuits 8 count packaged in 9 inch round aluminum cake pan 10 pans per case
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0834-2022·2022-04-06
FORE-SIGHT ELITE Tissue Oximeter: Inaccurate Oxygen Saturation Readings
Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.
Product
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2022·2022-04-06
Surgical Drill System Instrument Pack Recalled Over Device Breakage Risk
Wright Medical is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack due to risk that the drill guide can jam and break during surgery.
Product
EasyFuse Dynamic Compression System Instrument Pack
Category
Medical Device
Distribution
4 states
HighFDA (Drugs)·D-0732-2022·2022-04-06
Testosterone Cypionate Injectable Recalled Due to Lack of Sterility Assurance
Drug Depot, Inc. is recalling 620 vials of Testosterone Cypionate/DHEA injectables due to lack of sterility assurance in manufacturing. The product was distributed nationwide.
Product
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0728-2022·2022-04-06
FDA Recalls Gonadorelin Injectable Vials for Lack of Sterility Assurance
Drug Depot, Inc. is recalling Gonadorelin 0.2 mg/mL injectable vials distributed nationwide due to lack of sterility assurance. Approximately 6,017 vials are affected.
Product
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0841-2022·2022-04-06
Radiographic system software error may cause unintended tube stand movement
Siemens is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.
Product
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0842-2022·2022-04-06
Ceramic Hip Femoral Head Component May Not Match Package Label
Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.
Product
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Category
Medical Device
Distribution
Distributed nationwide