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.
Modern Macaroni Co. is recalling Hula Brand Hana Ebi Green shrimp flakes because FDA testing found sulfites in the product.
Teleflex Medical is recalling Aqua 540 SW and 540 w/040 Adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
The Coca-Cola Company is recalling specific lots of Coca-Cola Vanilla due to undeclared aspartame. Consumers should check their cans for the specific date code.
Hospira is recalling 36,881 GemStar infusion pumps because the beeper subassembly connection may fail, rendering the device inoperable.
Teva Pharmaceuticals is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg, due to a customer complaint trend regarding capsule breakage.
Modern Macaroni Co. is recalling Hana Ebi Red shrimp flakes due to high sulfite levels found by the FDA.
Healix Infusion Therapy is recalling 10 bags of BUPivacaine HCl 0.25% in On-Q C-bloc bags distributed in Texas due to visible particles.
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Kova Laboratories is recalling Amerigel Wound Dressing 1 oz. tubes because they may not have been manufactured pursuant to a validated process protocol and CGMP.
United Therapeutics is voluntarily recalling Tyvaso Inhalation Systems with specific medical devices that may have incorrect software, potentially causing them to not operate as instructed.
Teleflex Medical is recalling Humidifier Adaptor 040 units because creased packaging seals may affect integrity. The recall covers 7,758,650 units distributed worldwide.
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy in specific instructions.
Aesculap is recalling 11 units of non-sterile Dafilon sutures because an additional label incorrectly states the product is sterile.
Teleflex Medical is recalling Aquapak SW/EAU Sterile respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Philips is recalling 33 Gemini TF PET/CT systems because a software error can prevent the emergency stop from closing, rendering the equipment inoperable for clinical use.
Teleflex Medical is recalling Aquapak 101 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Kova Laboratories is recalling 3 drums of Amerigel Wound Dressing because the product may not have been manufactured according to validated protocols and CGMP.
Teleflex Medical is recalling 7.7 million Humidifier Adaptors because creased packaging seals may affect integrity. The products were distributed in the US and 12 other countries.
Oaxaca Mexican Products is recalling Anelina in 1/2 oz plastic bags because the product contains undeclared and unapproved colors.
GSK is recalling Panadol Advance pain relievers sold in Puerto Rico because the bottles do not meet child-resistant closure requirements.
Integra LifeSciences is recalling 1,250 LED battery chargers because they may fail prematurely and not charge the LED battery as intended.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur HCY Diluent because dilution recovery was lower than reported in the instructions for use.
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.