Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
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.
SureStep Foley Tray Systems, REF A303414A lot NGJY3685, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 units are affected.
Lippert is recalling specific paddle latches used on REV Recreation Group vehicles because they may lock unintentionally, preventing access to the liquid propane compartment and increasing fire risk.
Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles are affected.
UniCel DxH 900 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Abdallah Candies Cream Caramels, Milk, item 2210L in a 6.26 lb box, are recalled for undeclared peanut and pecan. One box distributed in Pennsylvania is affected.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2CN, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 65 units are affected.
B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags are affected.
Charge-Up Chilaquiles, 3.5 oz, lot 52061, is recalled because Yellow #5 and Yellow #6 are undeclared. 566 packages are affected.
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units are affected.
Bake-a-holic Cheesecake Royale Pecan Bars are recalled because a label review found milk and dairy absent from the Contains statement and soy removed from the label. 60 cases are affected.
Fagron Sterile Services bevacizumab (Avastin) Injection, 1.25 mg/0.05 mL single-dose syringes, is recalled nationwide for lack of assurance of sterility. 109,320 syringes are affected.
SureStep Foley Tray Systems with Bard Lubri-Sil catheters, REF A942216 lot NGJX4320, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating. 3,670 units are affected.
Bulk frozen raw half shell oysters, 15 lb, from harvest dates in January 2025 are recalled because the product is potentially contaminated with norovirus. 1,705 cases are affected.
Frozen Mercado Kroger Cooked Shrimp pieces, medium peeled tail-off, in 2 lb packages, are recalled because the product may be contaminated with Cesium-137. 18,000 bags are affected.
SureStep Foley Tray Systems, REF A303316A lot NGJX6399, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
Sun Pharmaceutical's Kit for the Preparation of Technetium Tc 99m Mertiatide, lot AD70995, is recalled after an out-of-specification result for sulphate in the sodium tartrate dihydrate used in production. 1,870 kits are affected.
Campsite Lentejas, 4.0 oz, lot 52060, is recalled because Yellow #5 and Yellow #6 are undeclared. 154 packages are affected.
AquaStar Cocktail Shrimp with cocktail sauce, 6 oz packages sold at Walmart, is recalled because the product may be contaminated with Cesium-137. 22,500 cases are affected.
The Vercise Deep Brain Stimulation Systems Surgical Implant Manual is being recalled after wire breaks in rechargeable pulse generators implanted in the submuscular pectoral location. 25,260 units are affected.
Sand Bar, Great American and First Street branded frozen raw shrimp in 2 pound bags is recalled because it was made under insanitary conditions and may have been contaminated with Cesium-137.
A handheld ultraviolet-C germicidal wand is recalled because it emits an unsafe level of UVC radiation, reaching the Risk Group 3 exposure limit in about 2.2 minutes and risking skin and eye injuries.
Frozen AquaStar Breaded Butterfly Shrimp, clean-tail, in 3 lb packages is recalled because the product may be contaminated with Cesium-137. 126 cases are affected.
Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.
UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.