Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
Wee Gallery is recalling about 8,000 Baby Tummy Time Gallery products because the clear plastic pockets contain phthalate levels that exceed federal limits. Phthalates are toxic if ingested by young children.
Reser's Fine Foods is recalling Walmart Original Freshness Guaranteed Macaroni Salad due to foreign material contamination. Affected product has UPC 78742 02670 with a Use By date of Sep 18, 2024.
Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.
Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.
Reser's American Classics Spicy Pickle Potato Salad (16 oz, UPC 71117 19084) is being recalled due to possible foreign material contamination. The voluntary recall affects products distributed across nine states.
Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.
Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.
Reser's Fine Foods is recalling Amazon Fresh Fresh Classic Macaroni Salad due to foreign material contamination. The product was distributed in nine states with a use-by date of September 13, 2024.
Just Right 5000 fluoride dental product is being recalled due to a label mix-up affecting 120 direct customers nationwide.
Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.
Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.
Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.
Reser's recalls 104 cases of sweet corn with butter due to shipment temperature abuse that may cause spoilage. Use By date Sept. 9, 2024; distributed in CA, IL, MN, ND, and SD.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.
Reser's American Classics Macaroni & Cheese White Cheddar (12oz) is recalled due to potential spoilage caused by temperature abuse during distribution. Consumers should discard affected packages.
Reser's American Classics Egg Salad has been recalled due to potential spoilage caused by temperature abuse from a malfunctioning refrigeration unit. The affected product was distributed in five states.
Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.
Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.
Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.
Reser's American Classics Macaroni & Cheese (12 oz) is recalled because a malfunctioning refrigeration unit caused temperature abuse during shipment, which may cause spoilage.
Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.
Reser's Fine Foods recalls Baked Scalloped Potatoes due to potential spoilage from temperature abuse during shipment. Affected products have Use By dates of September 11–13, 2024.
Reser's Fine Foods recalls Asiago Creamed Spinach due to potential spoilage from temperature abuse during transport. The affected product has a use-by date of August 31, 2024.
Reser's Essential Everyday Original Potato Salad recalled due to potential spoilage from temperature abuse affecting refrigerated units. Affected cases distributed in CA, IL, MN, ND, and SD.