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.
Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.
Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.
Philips MR 7700 Magnetic Resonance systems may have an improperly installed diagnostic cable. The cable does not impact system functionality or patient safety.
Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.
B. Braun Medical Inc. is recalling 43,812 bags of 0.9% Sodium Chloride Injection due to incomplete or missing labeling, including warnings and instructions for use.
Medtronic is recalling InterStim Self-Adhesive Ground Pad (lot 60347246) due to incorrect expiration date labeling. Affected units were distributed internationally including to Iran.
Philips Ingenia Elition S MR systems may have an improperly installed cable connecting the SmokeDetector Interlock to the host PC. This affects service diagnostics only and does not impact system functionality.
Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.
LINK MP Monoblock hip stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery or requiring procedure modification. No injuries or illnesses have been reported.
Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.
Philips is recalling 601 Ingenia Elition X MR systems because a diagnostic cable may not have been properly installed, though system operation is not affected.
Saxco International is recalling about 8,370 glass carboys because the glass can break due to improper cooling processes, posing a laceration hazard. The firm has received 30 reports of incidents of glass breaking, though no injuries have been reported.
Target is recalling about 2.2 million Threshold Glass Jar Candles because the glass jars can crack or break during use, posing laceration and burn hazards. Target received 19 reports of jars breaking or cracking, resulting in one minor injury.
WOW! Factor Desserts Berry Burst Slab Cake is being recalled due to possible norovirus contamination. The recall affects 333 cases distributed to CO, PA, OH, and MI.
Microtek Medical Inc. is recalling certain lots of surgical table drapes and infection control kits due to detection of naphthalene odor. The affected products are distributed nationwide in the US and in Canada.
Creganna Medical Devices is recalling three lots of Gore Tips Set Device due to incorrect expiration date labeling. Affected devices may be used past their actual expiration date.
Microtek Medical Inc. is recalling certain lots of Ecolab sterile medical device drapes due to naphthalene odor. The recall affects five models distributed in the United States and Canada.
Big J Mill & Elevator Company is recalling Golden Loaf Bakers Flour Unbleached Flour due to potential filth contamination. Approximately 900 cases were distributed to consignees in Utah.
The Ritedose Corporation is recalling Cromolyn Sodium Oral Solution (Concentrate) due to a manufacturing deviation. Lot 23CE2, distributed nationwide, was released prior to obtaining required supplier approval.
Big J Mill & Elevator Company is recalling Big J All Purpose Flour Unbleached Flour due to potential filth contamination. The recalled product was distributed to consignees in Utah.
Maggie's Farm Ltd. is recalling about 14,500 units of its 14-ounce Bed Bug & Flea Killer aerosol cans because they can rupture and expel shrapnel, posing injury and laceration hazards. The firm has received four reports of ruptures but no injuries have been reported.
Winter Gardens Quality Foods is recalling Trader Joe's Unexpected Broccoli Cheddar Soup due to insects found in frozen broccoli florets. The recall affects 10,889 cases distributed to FL, IL, CA, TX, WA, PA, and CT.
Kramer Laboratories is recalling Safe Tussin DM Cough + Chest Congestion due to a manufacturing deviation involving non-food grade lubricant in the mixing vessel. Affected lots 8753, 8753A, and 8659 were distributed nationwide.
FDA analysis found Natural Systems Naturasys Multi Vitamin contains magnesium at only 33.5% of the labeled amount. The recall affects 554 bottles with lot 38883 (expires 07/2024).
The A901 Communication Manager application did not receive a timely update to match the A710 Clinician Programmer software release for Intellis Neurostimulation Systems, creating a version mismatch.