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.
Swift Industries is recalling 9-inch rubber straps used to fasten bicycle bags because the straps can break, causing the bag to fall and creating a crash hazard to riders. No injuries have been reported.
Sterilization indicator products from Mckesson Medical-Surgical distributed nationwide may have been exposed to higher temperatures between June and August 2021. The temperature excursions may have impacted product effectiveness in verifying sterilization processes.
Mckesson Medical-Surgical is recalling SPS Medical sterilization indicator strips due to temperature excursions that may have reduced their effectiveness. Products distributed June–September 2021 are affected.
Baxter Healthcare is recalling Starling Monitor devices and accessories due to incorrect Unique Device Identification (UDI) information on labels and non-compliant barcodes. Approximately 9,671 units distributed nationwide are affected.
ALMIRALL, LLC is recalling 5,315 tubes of Xolegel ketoconazole 2% gel because tests found the product failed viscosity specifications, with out-of-specification results showing values slightly higher than acceptable.
McKesson Medical-Surgical Inc. is recalling three Dynarex wet wipe products that may have been exposed to higher temperatures at the facility before delivery, potentially reducing their effectiveness. All lots received between June and September 2021 are affected.
Cooper Surgical PREFILTER, SMOKE EVAC prefilters are recalled because they were exposed to higher temperatures during storage from June through August 2021. This exposure may have reduced the product's effectiveness.
Six sterilization monitoring devices from STERIS Corporation were recalled due to temperature excursions during storage and delivery that may have compromised their effectiveness. Affected products were distributed nationwide between June and September 2021.
Mckesson Medical-Surgical is recalling monofilament sensory testing devices (13 units) due to temperature excursions during June-August 2021. Heat exposure may have compromised device effectiveness.
Viatris Inc recalls 3,931 cartons of Ampicillin for Injection after a complaint of a hair strand found in one vial. No illnesses have been reported.
Mckesson Medical-Surgical is recalling Dynarex Unna Boot Dressing products exposed to temperature excursions during June-August 2021. The manufacturer states the deviation is unlikely to cause health consequences, but products may have reduced effectiveness.
KerraCel Ag wound dressing units distributed between June and September 2021 are being recalled due to facility temperature excursions that may have affected product effectiveness. The FDA states no adverse health consequences are likely.
Leica Microsystems is recalling 32 surgical operating microscopes due to a photodiode component defect that produces inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.
SPS Medical Supply Crosstex sterilization rolls (model SCT3) are being recalled because they were exposed to high temperatures during manufacturing facility storage before shipment. Temperature exposure may have compromised the product's sterilization effectiveness.
Mckesson is recalling SafeWash Saline Wound Flush due to temperature exposure that may have reduced product effectiveness. The recall affects units distributed nationwide from June through September 2021.
Sun Pharmaceutical is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg nationwide due to superpotency findings. Lot AC14299 (expiration 12/2022) tested out of specification for drug assay at the 12-month stability timepoint.
McKesson is recalling Surgitube surgical bandages distributed between June and September 2021 that may have been exposed to elevated temperatures during storage. The FDA states the temperature exposure is unlikely to cause adverse health effects.
McKesson Medical-Surgical is recalling multiple calcium alginate wound dressings due to facility temperature excursions that may have impacted product effectiveness. The FDA states the affected products are not likely to cause adverse health consequences.
Mckesson is recalling Shur-Conform and ALGICELL wound care dressings due to temperature exposure affecting product effectiveness. All affected units were distributed June through September 2021.
An MK4 tibial bearing knee implant component was mistakenly supplied when an MK3 model was required. The mismatch was discovered during surgery and corrected by the surgeon.
McKesson is recalling LiquiBand Exceed skin adhesive products nationwide due to facility temperature excursions between June and August 2021. The FDA states the affected products are not likely to cause adverse health consequences.
Mckesson Medical-Surgical Inc. recalls skin markers used in medical imaging that may have been exposed to excessive temperatures during storage prior to delivery. Affected units were received between June and September 2021.
DermaCol 100 Collagen Powder was exposed to higher temperatures during storage from June to August 2021. The product's effectiveness may have been impacted, though the FDA determined no adverse health consequences are likely.
Sun Pharmaceutical is recalling Esomeprazole Magnesium capsules nationwide because the drug potency exceeds the specified level at the 12-month timepoint.
McKesson is recalling SporView Culture Set biological indicator kits (models CS-020 and CS-100) due to facility temperature excursions that may have compromised product effectiveness. Affected units were distributed nationwide between June and September 2021.