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.
IntegraDose Compounding Services recalled 281 syringes of Vasopressin 2 Unit/2 mL due to subpotency. The voluntary recall affects Lot #20230921VAS-2 distributed in Minnesota.
Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.
Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.
C.R. Bard is recalling 3,400 units of Bard Nasogastric Sump Tube with ENFit due to reports of inadequate suction, decompression, and drainage during use affecting patients requiring nasogastric care.
BD (C.R. Bard) is recalling Bard Nasogastric Sump Tubes with ENFit connectors because users have reported inadequate suction, decompression, and drainage. The devices may not function properly for their intended medical purpose.
Beckman Coulter recalls the iQ Waste Well Adapter due to rust in the cannula that may generate erroneous test results in laboratory diagnostic equipment.
B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.
Tornier, Inc is recalling 50 units of Stryker Tornier Perform shoulder implants because the incorrect device is contained in the labeled package. Affected batch: lot 6714AZ, serial 001–050.
Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.
C.R. Bard is recalling 3,650 units of Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate suction, decompression, and drainage during use. The issue could affect proper tube function in clinical settings.
C.R. Bard Inc. is recalling approximately 187,550 Bard Lopez Valve units due to user complaints of inadequate suction, decompression, and drainage during use. No illnesses or injuries have been reported.
DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.
Sun Pharmaceutical recalls 6,552 bottles of Niacin Extended-Release Tablets (1000mg) nationwide due to microbial contamination in manufacturing equipment. No illnesses have been reported.
BRS Fuel Bottles sold on Amazon from December 2020 through October 2023 do not have child-resistant closures as required by law, posing a risk of burn and poisoning to children. Consumers should stop using them immediately and contact the distributor for return or disposal.
About 12,440 Yaomiao children's tiaras with rhinestones sold on Amazon.com contain lead levels that exceed federal limits. Lead is toxic if ingested by young children and can cause adverse health effects.
Clark Associates is recalling about 53,800 Allegro plastic side chairs because the chairs can break apart while in use, creating a fall hazard. The company has received 16 reports of chairs breaking apart, resulting in two injuries.
The FDA has recalled Old Spice SWEAT DEFENSE PURE SPORT PLUS anti-perspirant spray due to potential benzene contamination found at the manufacturing facility. All lots through September 2023 are affected.
The CareEvent patient monitoring device may fail to send push notifications, potentially delaying detection of patient condition changes.
TreeHouse Foods is recalling Trader Joe's 32oz Turkey Stock due to potential microbial contamination. The product was distributed to 41 states.
Herold Salads, Inc. is recalling Cheddar Mac & Sour Cream salads due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, Pennsylvania, and Michigan.
Procter & Gamble is recalling Secret OUTLAST Dry Spray Antiperspirant due to a manufacturing facility deviation where other lots were found contaminated with benzene. The recalled product was manufactured at the affected facility.
Randox Laboratories has recalled multiple calibration serum products due to transcription errors in the Instructions for Use, which contain incorrect target values for several analytes.
A surgical guide used in knee replacement is recalled due to mislabeling showing incorrect dimensions. This could result in improper bone resection and implant fit, potentially extending surgery time.
Old Spice SWEAT DEFENSE Dry Spray anti-perspirant is being recalled due to manufacturing facility issues where other product lots were found contaminated with benzene. No illnesses have been reported.
VACUETTE blood collection tubes are missing an anticoagulant additive, causing samples to clot and producing inaccurate or absent lab results. This can delay diagnosis or lead to inappropriate treatment.