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.
Musculoskeletal Transplant Foundation is recalling 25 units of DBX Mix bone void filler because the outer packaging seal may not be fully intact.
Specialty Appliance Works is recalling Universal Nuts used in Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.
Exactech, Inc. is recalling 112 Equinoxe 44mm Short Humeral Head shoulder implant components because incorrect outer and inner labeling may misidentify the device size.
SenTec AG is voluntarily replacing V-Sign Sensor 2 units because a part of the PCO2 measuring unit deteriorates prematurely, disabling PCO2 monitoring. The recall affects 129 units in the US and 59 outside the US.
Focus Diagnostics is recalling 300 units of the Stratify JCV DxSelect assay (Lot 27333) because a non-conforming batch may cause false positive results.
PhotoMedex, Inc. is recalling Iamin Moist Dressings and Hydrating Gel because their labeling does not match the intended uses approved by the FDA.
Specialty Appliance Works is recalling 14,428 Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 SS instead of the specified 303 SS.
X Spine Systems Inc is recalling 14 units of Xpress System Pedicle Screw Assemblies because the laser marking on the yoke incorrectly states 7.5 x 55mm instead of 5.5 x 55mm.
Specialty Appliance Works is recalling Universal Nut components for Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.
Tarmac Products, Inc. is recalling Well at Walgreens Regular Strength Comfort Gel Cherry Flavor because the product failed the Antimicrobial Effectiveness Test.
Attix Pharmaceuticals is recalling Homatropine Methylbromide active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
Biomet Spine is recalling 874 Torque Limiting Handles used in spinal fixation due to supplier component updates.
Specialty Appliance Works is recalling Universal Nuts for MiniScope Mechanical Sets because they were made with 416 stainless steel instead of the specified 303 stainless steel.
Specialty Appliance Works is recalling Herbst Universal Nuts because they were manufactured with 416 SS instead of the specified 303 SS.
Specialty Appliance Works is recalling TS Herbst Nuts because they were manufactured with 416 stainless steel instead of the specified 303 stainless steel.
Specialty Appliance Works is recalling TS ROC Crown Components because the Universal Nut was made with 416 SS instead of the specified 303 SS.
Specialty Appliance Works is recalling Universal Nuts used in Herbst orthodontic appliances because they were made with 416 stainless steel instead of the specified 303 stainless steel.
Attix Pharmaceuticals is recalling Piperacillin Sodium active pharmaceutical ingredient because it was repackaged without data supporting the printed expiry date.
Attix Pharmaceuticals is recalling Amoxicillin Trihydrate active pharmaceutical ingredient because stability data does not support the printed expiry dates.
Catheter Research, Inc. is recalling 880 HSG trays and catheters because the flexible and shapeable catheters were mislabeled on the packaging.
Specialty Appliance Works is recalling Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 stainless steel instead of the specified 303 stainless steel.
Biomet Spine is recalling 148 Lineum HF Torque Handle Limit units because the supplier withdrew the product for component updates or reconfiguration.
Attix Pharmaceuticals is recalling Procaine Penicillin G active pharmaceutical ingredient because stability data does not support the printed expiry dates on repackaged lots.
Walong Marketing is recalling Wu Fu Yuan Sago Taro because it contains unapproved FD&C Red #2.
Specialty Appliance Works is recalling Universal Nuts for orthodontic Herbst Appliances because they were made with 416 stainless steel instead of the specified 303 stainless steel.