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.
Wright Medical Technology is recalling 47 units of VALOR Nails that may be missing an assembled compression screw.
Philips is recalling 12 Ingenuity TF PET/CT systems because the mass storage device may cause the acquisition console to become unresponsive, preventing image acquisition.
Datascope is recalling Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use were missing the Contraindications section.
Swire Coca Cola is recalling 366 cases of Dr. Pepper Est. 1885 Diet, 20 FL Oz bottles due to the potential presence of foreign material.
Diamond Wipes International is recalling WipeEssentials Wet Wipes because they were manufactured with poor quality water.
AvKARE Inc. is recalling 2,135 cartons of Amantadine HCl Capsules, 100 mg, because the product failed dissolution specifications.
Datascope is recalling 655 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions For Use were missing the Contraindications section.
Taylor Shellfish Co is recalling smoked scalps in Oregon and Washington because the product did not meet minimum salt requirements.
Ethicon is recalling PDS Plus Antibacterial Sutures because three lots were labeled with an incorrect five-year expiry date instead of the correct two-year date.
ICU Medical is recalling 100 pouches of 5-inch Smallbore Extension Sets because they were manufactured with an incorrect spin collar.
ICU Medical is recalling 7,600 sterile intravascular administration sets because they were manufactured with an incorrect spin collar. The sets were distributed in the US, Canada, and Japan.
Ethicon, Inc. is recalling PDS Plus Antibacterial Sutures because three lots were labeled with a five-year expiry date instead of the correct two-year date.
Pepsi Cola Bottling Company is recalling Diet Pepsi 6-packs because the outer packaging incorrectly states the product is 'Now Aspartame Free' when it actually contains aspartame.
ICU Medical is recalling 11,500 smallbore extension sets manufactured with incorrect spin collars. The affected units were distributed in the US, Canada, and Japan.
Smith & Nephew is recalling D-RAD Self-Tapping Locking Screws because they were machined out of specification. The screws measured over tolerance within the head thread form.
Teleflex Medical Europe Ltd is recalling Simplastic Suprapubic Puncture Instruments because the packaging lacks a required warning that the products contain natural rubber latex.
ICU Medical is recalling 2,950 sterile 7-inch smallbore infusion sets because they were manufactured with an incorrect spin collar. The affected lots were distributed in the US, Canada, and Japan.
Elroselabs Inc. is voluntarily recalling Conzerol Hydrogen Peroxide Gel 3% nationwide due to current Good Manufacturing Practice (cGMP) deviations.
Certified Safety Mfg Inc is recalling 748 first aid and emergency kits containing Honeywell eyewash due to leaking bottles. The affected units were distributed nationwide.
Nidek Inc. is recalling 63 ARK-1s Auto Ref/Keratometers because there may be a difference between subjective and objective dioptric measurements.
Teleflex Medical Europe Ltd is recalling 200 Baker Jejunostomy Tubes because the packaging lacks a required warning that the product contains natural rubber latex.
ICU Medical is recalling specific lots of sterile intravascular administration sets because they were manufactured with an incorrect spin collar.
Elroselabs Inc. is voluntarily recalling Conzerol topical cream nationwide due to cGMP deviations. The recall was initiated in March 2018 and terminated in December 2020.
Elroselabs Inc. is voluntarily recalling Molleave, 2 oz bottles, due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.
Teleflex Medical Europe Ltd is recalling 6,340 rectal catheters because the packaging lacks a required warning that the product contains natural rubber latex.