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.
Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.
Smiths Medical is recalling the medex TranStar Stopcock due to a manufacturing defect that can cause inaccurate pressure monitoring, interrupted pressure monitoring, or inability to zero the device.
Smiths Medical is recalling the medex TranStar Pressure Transducer Kit due to manufacturing defects that may cause inaccurate pressure monitoring or inability to zero the device.
Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.
Baxter Healthcare is recalling the TruSystem 7000 V operating table due to reports of battery and connector short-circuits and smoke emissions. Four units with worldwide distribution are affected.
Farmers Juice Carrot Digest is being recalled for incomplete pasteurization, which fails to eliminate harmful bacteria. About 2,521 bottles were distributed across multiple U.S. states.
Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.
Smiths Medical ASD Inc. is recalling 251,591 Portex Nasopharyngeal Airway units worldwide due to uncertainty in sterile packaging seal integrity, potentially compromising the sterile barrier.
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.
Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.
Baxter is recalling its TruSystem 7000 operating table worldwide due to customer reports of battery and connector short-circuits that emitted smoke. All serial numbers are affected.
Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.
CFMOTO is recalling about 2,650 of its 2024 CFORCE 800 Touring and 2024 CFORCE 1000 Touring ATVs because the throttle lever can fail to return to idle, causing unexpected acceleration and crash risk. One minor injury has been reported.
Boston Scientific is recalling the AVVIGO+ Guidance System for a software defect that displays incorrect grid overlays when connected to OptiCross 18 catheters. The error affects Live and Record modes only; no injuries have been reported.
XTANT Medical is recalling 330 Cortera spinal fixation system screws marked 'DNI' because they may not have been manufactured to specification and could lack adequate strength if implanted.
Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.
The Boston Scientific AVVIGO+ Guidance System displays an incorrect grid overlay when used with the OptiCross 18 catheter in Live or Record mode, potentially affecting depth reference settings. No injuries have been reported.
Medline Industries recalls certain open-heart surgical kits (Lot 23LBR364) due to incorrect model labeling, where model 30001 units were labeled as model 30000. The recall affects 30 units distributed nationwide.
Boston Scientific is recalling the AVVIGO+ Guidance System due to a software bug displaying incorrect grid marks during live imaging. The device shows 9 grid marks instead of 15, which could affect accurate vessel measurement in cardiac interventions.
Lemonland Food Corp recalled stir-fried dried shrimp (Item FLD1971) distributed in Washington because wheat is not declared on the label, despite being present in the product.
Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.
Hydration Labs Inc. is recalling Flavor#115 Electrolytes (3.78L BIB units) distributed nationwide and in Canada because the product is labeled as electrolytes but actually contains caffeine.
Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential fall hazard. The backrest may disengage when users shift from a slouched to upright seated position.