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.
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Zimmer CAS is voluntarily recalling Navitrack System OS Knee Universal software versions due to software issues causing errors and discrepancies.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Insulin ReadyPacks because the assay results are approximately 40% higher than the WHO standard. The company states the overall risk to health is negligible.
Teleflex Medical is recalling Visistat 35R Disposable Skin Staplers because some boxes are mislabeled as containing Wide devices when they contain Regular devices.
Ziehm Imaging Inc is recalling two solo FD Mobile Fluoroscopic C-arm systems because the labels for the Collimator and X-ray Control panel are missing the manufacturer date.
Beckman Coulter is recalling HDL Cholesterol Reagent because specific drugs can cause false low results.
Medical Action Industries is recalling specific lots of Blue OR Towels because lint was found on the sterile towels.
Hitachi Medical Systems America Inc is recalling 77 Arietta 70 Ultrasound Systems because the arm mounting mechanism was insufficiently strong and required redesign.
Beckman Coulter is recalling Enzymatic Creatinine Reagent because specific drugs can cause false low results. The recall affects 12,665 units distributed worldwide.
Kemps, LLC is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Beckman Coulter is recalling Uric Acid Reagent because certain drugs can cause false low results. The recall covers 100,286 units distributed worldwide.
Kemps, LLC is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Beckman Coulter is recalling Lactate Reagent (Catalog No. A95550) because certain drugs can cause false low results.
Medical Action Industries is recalling sterile operating room towels because lint is present on the product.
John Morrell and Co. is recalling approximately 210,606 pounds of beef frank products due to possible metal contamination. No injuries have been reported.
Zimmer Biomet is recalling specific lots of Cobalt bone cement because a breach in the sterile Tyvek packaging could lead to loss of sterility.
Siemens is recalling 159 RAPIDPoint 500 Blood Gas Analyzers because a blank patient ID field may cause demographic errors.
PAR Sterile Products LLC is recalling Buprenorphine Hydrochloride Injection due to the presence of white, crystalline particulates in the vials.
Smith & Nephew is recalling 12 units of Peri-Loc Volar Distal Radius plates that were laser-etched as left plates but packaged as right plates.
Medtronic is recalling 36 units of PAK Needle Beveled and Trocar Tips because packaging may contain incorrect needle types instead of the required combination.
Zimmer Biomet is recalling 49 Bone Dowell Harvest Tubes that were mislabeled as 8mm but are actually 9mm in size.
Zimmer CAS is recalling 34 NDI P7 Position Sensors due to a manufacturing issue that may cause them to stop functioning during use.
CooperSurgical is recalling lnflatoball Latex Rubber Pessaries because the secondary packaging incorrectly states the product is latex-free, despite being made of 100% latex.
Med-Hot Thermal Imaging, Inc. is recalling 12 units of the MTI 2000 Thermal Imaging System because the indications for use are not cleared or approved for the U.S. market.
Stryker is recalling 65 PROFESS Registration Kits shipped near or past their expiration dates. The kits are used for intranasal and sinus surgery.