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.
Stryker is recalling 5,800 AccuPlace Drace Stereotaxic Needle Guides due to a potential breach in sterility caused by packaging damage.
Volcano Corporation is recalling certain lots of R-100 Sterile Equipment Covers because the outer shipping boxes may display incorrect expiry dates, although the inner product is correctly labeled.
The FDA is recalling 1,010 units of pediatric feeding tubes because 8FR PVC tubes were incorrectly packaged in 6.5FR polyurethane packs.
Teva North America is recalling 1,895 bottles of Capecitabine tablets because they failed dissolution specifications at the 18-month time point.
Smith's Country Cheese is recalling Gouda with Sundried Tomato & Basil Spread due to contamination with non-pathogenic E. Coli.
Zimmer Spine is issuing a Class II correction for the Virage OCT Spinal Fixation System to provide additional guidance in the surgical technique manual.
Smith's Country Cheese is recalling Gouda with Herb Spread due to non-pathogenic E. Coli contamination. The product was distributed in Georgia, New Hampshire, and Massachusetts.
EKOS Corporation is recalling 10 units of the EkoSonic Endovascular System because the device is labeled with a 135 cm working length, but the actual working length is 106 cm.
Zimmer Biomet is recalling 4,844 Versys hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Medtronic is recalling Specify 5-6-5 and 2x8 spinal cord stimulation leads because the labeling does not adequately distinguish between permanent implant and trialing use.
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Jody's Gourmet Popcorn is recalling Fabulous Fudge Chocolate Walnut fudge because consumers reported mold on the product before its expiration date.
Biomet is recalling 23 HipLOC CHS Plate/Lag Screw Introducers because some units are undersized and fail to accept the coupling screw.
Zimmer Biomet is recalling specific CR Flex and Natural Knee prosthesis components because the LDPE packaging bag adheres to the polished implant surface.
Zimmer Biomet is recalling 13,483 Natural-Knee II femoral prostheses because the LDPE packaging bag adheres to the polished implant surface.
Hospira is recalling 6,634 Symbiq infusion pumps because the pole clamp assemblies may be missing a rubber stop pad. The devices were distributed to healthcare facilities in the U.S. and Canada.
Sorin Group USA is recalling CDI H/S Cuvettes because they may fail to connect properly with the probe, causing the monitor to display an error and preventing blood parameter values from displaying.
Cook Inc. is recalling 25 Flexor Check-Flo Introducers because some packages labeled as 6.0Fr actually contained 5.0Fr devices.
Leica Microsystems is recalling the Bond Polymer Refine Detection System because it may not provide adequate staining when used with specific protocols.
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Zimmer Biomet is recalling NexGen LPS Flex femoral knee implants because the packaging bag adheres to the polished implant surface.
President East Company is recalling frozen kingfish steaks because FDA analysis found the product was decomposed and actually Spanish mackerel.
Stryker Howmedica Osteonics Corp. is recalling Gamma Guide Pins because a packaging review indicated that the seal integrity of the pouch may be decreased.
Zimmer Biomet is recalling 5,103 Gender PFJ Femoral Components because the LDPE packaging bag adheres to the implant surface. The device is distributed worldwide.
Zimmer Biomet is recalling 130 units of Versus 6 Inch Beaded FC 1 hip prostheses because the packaging bag adheres to the implant surface.