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.
Elekta, Inc. is recalling the Monaco TRP System software because it may incorrectly handle CT datasets with specific DICOM Z coordinates, potentially affecting treatment plan accuracy.
Mel-O Cream Donuts International is recalling 20 cases of Arrowhead/Christmas Tree Shells because a human fingertip was found in the product filling line.
MicroPort Orthopedics is recalling specific Cobalt Chromium hip replacement heads because internal data showed an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.
Burel Pharmaceuticals is recalling AZUPHEN MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.
Burel Pharmaceuticals is recalling specific lots of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in assay or content uniformity failures.
Nationwide Laboratories is recalling Salsalate Tablets, 750 mg, because they were manufactured under practices that may result in assay or content uniformity failures.
Terumo BCT is voluntarily recalling 660 units of the Adiprep Adipose Transfer System because incorrect labeling could cause operator confusion.
Siemens is recalling 33 Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems because the material covering the articulating section has deteriorated, causing acquisition errors.
Sorin Group USA is recalling Stöckert Heater Cooler System 3T units to ensure strict adherence to disinfection and monitoring instructions.
Mel-O Cream Donuts International is recalling specific batches of Hy Vee Shells (Bavarian Filled) because a human fingertip was found in the product filling line.
Spectranetics is voluntarily recalling the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon because their outer sterile packaging may be compromised.
Terumo Medical Corp is recalling 7,965 MISAGO RX Self Expanding Peripheral Stents nationwide because they do not conform to product specifications regarding diameter and shape.
Nationwide Laboratories is recalling Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in assay or content uniformity failures.
Mel-O Cream Donuts International is recalling specific batches of Hy Vee Long Johns because a human fingertip was found in the product filling line.
Nationwide Laboratories is recalling Salsalate Tablets, USP, 500 mg, because they were manufactured under practices that may result in assay or content uniformity failures.
Baxter Healthcare is recalling 439 V6 Rear Case Assemblies for SIGMA Spectrum Infusion Pumps because the speakers may fail prematurely.
MicroPort Orthopedics is recalling 500 units of Procotyl Rim-Lock Liners because revision rate trends indicate a specific hazard of tissue reaction to metal debris.
Baxter is recalling SIGMA Spectrum Infusion Pumps to replace speakers that may fail prematurely, potentially affecting audible alarm tones.
Merge Healthcare is recalling Merge FlexConnect software version 1.0 because communication protocols were not properly handled, preventing data from being processed by the LIS software.
Burel Pharmaceuticals is recalling 2,861 bottles of Hyolev MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.
Burel Pharmaceuticals is recalling UROPHEN MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.
Burel Pharmaceuticals is recalling Uramit MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.
ConforMIS is recalling two sterile iTotal Knee Replacement Systems distributed to Colorado and Nevada due to incorrect serial numbers on the F4 A/P cut guide iJig.
Teleflex Medical is recalling 113,647 units of Arrow OnControl Bone Marrow Biopsy System Trays due to a potential incomplete seal on the outer sterile package.
Nationwide Laboratories LLC is recalling Phenazopyridine Hydrochloride Tablets, 200 mg, due to manufacturing deviations that may result in assay or content uniformity failures.