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.
Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.
Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.
Macleods Pharmaceuticals is recalling Olanzapine 2.5 mg tablets nationwide due to failed impurities and degradation specifications. The recall affects one production lot distributed across the United States.
CooperSurgical's K-Systems R65 Trolley reproductive incubators may experience temperature excursions above desired setpoints, though devices will alarm when this occurs. The FDA issued a Class II recall of 43 units across eight U.S. states.
Gelato Benzocaine 20% topical anesthetic (Lot BNZ-001646) is recalled due to scratches found in the mixing vessel during manufacturing. The defective product was inadvertently released despite quality control rejection, though no illnesses have been reported.
Augustine Temperature Management is issuing an instructions for use update for its HOT DOG warming controllers (Models WC77, WC77D, WC77R) regarding a power-on self-test error code.
Keystone Industries is recalling one lot of Patterson Dental Topical Anesthetic due to manufacturing quality deviations. The product was shipped despite being marked for rejection due to scratches in the mixing vessel.
Spacelabs Healthcare is recalling the Eclipse Mini ECG patch recorder because incorrect serial numbers may be programmed into devices, causing a mismatch between the physical label and internal serial number.
Henry Schein's Benzo-Jel Topical Anesthetic Gel is being recalled due to manufacturing quality deviations. Scratches were discovered on the mixing vessel after the product had been inadvertently released and distributed to customers.
MicroPort Orthopedics recalls EVOLUTION MP femoral knee prosthesis components due to incorrect packaging. The devices are correctly marked internally but may have wrong labels on their packaging.
Spacelabs Healthcare recalls 13,202 Eclipse PRO Holter recorders due to manufacturing error where the programmed serial number may not match the physical label. Affected devices were manufactured between April 2021 and November 2024.
Keystone Industries recalls Ipana 20% Benzocaine Topical Gel due to a manufacturing quality issue. The bulk product was released from a mixing vessel with scratches despite Quality Unit rejection.
Keystone Industries recalls Burkhart Topical Anesthetic Gel due to CGMP deviations discovered during quality inspection. The product was inadvertently released despite being flagged for rejection.
Provepharm Inc. is voluntarily recalling Dihydroergotamine Mesylate Injection nationwide due to discoloration in specific lots. Patients should contact their healthcare provider if they have used the affected product.
Augustine Temperature Management is updating instructions for HOT DOG Patient Warming Controllers (Models WC71, WC71R) regarding a power-on self-test error code. The update affects 135 units distributed in the US and Canada.
Safco SensiCaine Ultra Topical Anesthetic Gel is being recalled due to a manufacturing process deviation. Product that should have been rejected because of damage to the mixing vessel was inadvertently released to customers.
LNK International recalls Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The product should not have been released and was distributed to wholesale customers.
Dr. Reddy's Laboratories is recalling 7,233 bottles of JAVYGTOR (sapropterin dihydrochloride) tablets nationwide because the medication failed specifications for impurities and degradation products. Affected patients should contact their healthcare provider.
Small DKS Disposable Kerrison System instrument sets were inadvertently distributed when not intended for commercial distribution. Six sets (Lot 1578) were distributed to Kansas, Louisiana, Michigan, New York, and Texas.
Nestle Health Science recalls Nutren 2.0 pouches mislabeled as Isosource 1.5. The labeling error affected 5,754 units distributed across 16 states.
ICU Medical is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80) due to incorrect packaging and labeling of finished goods. Units were distributed in Illinois and Canada.
Hologic is recalling 178 units of Sizer Set surgical instruments nationwide because instructions for use and revised sterilization instructions were not provided with the product.
Biocompatibles is recalling 432 Varithena (polidocanol injectable foam) Administration Packs due to incorrect syringe connectors. The packs contain luer lock syringes instead of the required luer slip connection syringes.
Cumberland Packing Corp. is recalling Organic Hot Agave in the Raw, 10 oz., due to elevated osmophilic yeast count. Affected product was distributed across 18 states.
Medline Industries is recalling 30,092 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.