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.
Pulmonx endobronchial valve devices may have been labeled with a shortened expiration date. The devices are usable until December 8, 2024.
Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.
OXAYDO oxycodone 7.5 mg tablets distributed nationwide are being recalled because they contain lower potency than labeled. The affected lot is 22W02 with expiration 01/31/2025.
Family Dollar recalls 329,044 units of GoodSense denture cleanser tablets that were stored outside their labeled temperature requirements. Products were sold between June and October 2023 at Family Dollar stores across 24 states.
Family Dollar's MEDIC's CHOICE contact lens solution was distributed between June and October 2023 due to storage outside labeled temperature requirements. Approximately 329,044 units were affected across 22 states.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The label states a 54-month shelf life when the actual shelf life is 36 months.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an error in the product label's expiration date. The label indicates a 54-month shelf life when the actual shelf life is 36 months.
Textron Specialized Vehicles is recalling about 1,660 E-Z-GO ELiTE Express and Tracker OX EV vehicles because internal motor wiring damage can cause the vehicle to move unintentionally, creating a crash hazard. One incident of unexpected movement has been reported but no injuries.
Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurities and degradation specifications. The recall affects 480 bottles distributed nationwide.
Edenbridge Pharmaceuticals recalled opium tincture nationwide because the morphine concentration fell below labeled potency. The voluntary recall affected 4,548 bottles.
Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.
Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.
Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.
Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.
Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.
Safecor Health recalls Strong Iodine Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The prescription product was distributed in multiple lots across the U.S.
Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.
Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.
Denver Solutions recalls 6,276 IV bags of oxytocin due to a labeling defect. The product was distributed nationwide to healthcare facilities.
Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.
Empatica has recalled 1,360 units of its Embrace2 seizure monitoring wearable due to potential battery life lasting less than the specified 48 hours, requiring more frequent charging.
Medtronic is recalling Grafton DBM Putty bone matrix implants because the outer Tyvek pouch inspection step may not have been performed, potentially releasing non-conforming batches.
Universal Meditech Inc. is recalling multiple diagnostic test strips (breastmilk alcohol, SARS-CoV-2 antibody, and ketone tests) distributed in the U.S. and Taiwan because the company is closing and cannot provide documentation of manufacturing compliance or post-market surveillance records.
Medtronic is recalling specific serial numbers of Grafton DBM Matrix Strips due to a potential defect in the outer Tyvek pouch resulting from a missed inspection step during manufacturing.
Denver Solutions is recalling 33,480 Vancomycin HCI IV bags (NDC 71449-028-68) due to a labeling issue. The affected lots were distributed nationwide.