Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
Philips has recalled certain surgical C-arm imaging systems delivered to Puerto Rico because they lack required warning labels and are missing a critical Source-to-Skin Distance Spacer component.
B. Braun Medical is recalling AMO ophthalmologic administration sets due to a manufacturing defect causing potential leakage. This may delay therapy and expose patients and healthcare workers to hazardous medication.
Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters that may deflate more slowly than normal, potentially affecting device function during vascular procedures.
Philips is recalling 101 ProxiDiagnost N90 radiography and fluoroscopy systems due to potential failure of ceiling-mounted units, which could fall and cause injury.
Philips EasyDiagnost Eleva DRF digital radiographic systems mounted on ceilings may fail and fall. 40 units nationwide are being recalled due to potential ceiling mount failure.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an expiration date labeling error. The label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.
Carestream Health is recalling 2,402 DRX-Revolution Mobile X-Ray Systems due to potential electrical failure in the generator causing thermal overload. The system becomes inoperable and may produce loud noise, burnt smell, and smoke.
Stryker Corporation recalled 19 Portal Entry Kits distributed to surgical facilities in multiple U.S. states due to expired product. The kits aid surgeons in establishing arthroscopic portals.
Stryker Corporation is recalling 2,321 units of disposable surgical forceps due to a labeling error. The label indicates a 54-month shelf life, but the products actually expire in 36 months.
Stryker Corporation is recalling 2,321 Spetzler-Malis bipolar surgical forceps due to incorrect expiration date labeling. The product label states a 54-month shelf life when the actual shelf life is only 36 months.
Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.
Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides due to measurement abnormalities that could result in falsely low or elevated test results. This could delay diagnosis of acute pancreatitis or cause diagnostic confusion.
Hinterland Dairy Inc is recalling Farmstead Cheese Mango Habanero (8oz packages, Lot 1670) distributed in Iowa due to potential E. coli contamination. Consumers should dispose of the product.
Philips is recalling Integris-Allura IGTS Fixed Systems delivered to Puerto Rico, Guam, and the Virgin Islands due to missing Source-to-Skin Distance Spacers and required warning labels.
Change Healthcare Radiology Solutions versions 14.0, 14.1, and 14.2 may fail to update records in external applications. Healthcare facilities using this software are affected across six countries.
Stryker Corporation is recalling 2,321 units of disposable bipolar surgical forceps with incorrect expiration dates on their labels. The devices are labeled with a 54-month shelf life when the actual shelf life is 36 months.
Philips is recalling 7 Affiniti 70 diagnostic ultrasound systems with software version 10.0 due to a defect that may produce delayed imaging instead of real-time images.
Gills Onions, LLC is recalling Cross Valley Farms diced yellow onions due to potential contamination with Salmonella Thompson. The product was distributed across the United States and Canada.
Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.
Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.
Family Dollar is recalling DENTEMP ONE STEP temporary dental fillings sold between June 2023 and October 2023 in 22 states because they were stored outside labeled temperature requirements, which may affect product performance.
Philips Azurion IGTS Fixed Systems delivered to U.S. territories lack required safety components. The Source-to-Skin Distance Spacer and warning label are missing from affected units.
DigitalDiagnost 4 High Performance radiographic systems may fail and fall from ceiling mounts. The FDA recalls 366 units distributed nationwide.
Breg Inc is recalling 11,193 folding walkers with misaligned wheels that do not meet product specifications. The defect could affect stability and increase fall risk.
Alcon Custom-Pak surgical procedure packs contain latex gloves but are labeled as 'latex-free,' posing an allergic reaction risk for healthcare workers and patients with latex allergies.