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.
Innovative Orthopedic Technologies is recalling the ARCH Leg Positioning System due to manufacturing defects that prevent locking pins from properly engaging under load.
ZOLL Circulation is recalling the COOLINE Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. 2,833 units are affected globally.
Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.
ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.
ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.
Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.
Zoll Circulation recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to potential leaks from the catheter or start-up kit tubing.
ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit due to potential leaks in catheter and tubing components. The Class II recall affects 79 bundles distributed worldwide.
ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.
Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.
ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles distributed worldwide.
ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.
ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.
Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.
Philips Ultrasound recalls the Sparq diagnostic ultrasound system due to a battery system data issue causing intermittent device shutdowns, regardless of actual battery status or AC power connection. Affected units were distributed in 10 US states and internationally.
HME is recalling one 2014 Ford F-550 emergency vehicle because the dashboard may fail to warn drivers of emissions system faults, potentially causing loss of power.
Winnebago is recalling 2019-2022 Travato and 2021-2022 Boldt RVs. A faulty wire harness may lose over-current protection, causing wires to overheat and increasing fire risk. Owners must not drive until the Volta Power System is disabled.
Mercedes-Benz is recalling 2021 S 500 and S 580 vehicles because a software defect may deactivate the front passenger air bag, increasing injury risk in a crash.
HME is recalling 245 fire trucks from 2017-2020 because a sealing washer may not seat correctly, allowing the high-pressure fuel rail to leak and increasing fire risk.
Foretravel is recalling 2020-2022 iH-45, Realm, and iC-37 recreational vehicles because window adhesive may fail, causing the vent to detach and increasing crash risk.
Forest River is recalling 2012-2016 Starcraft transit buses because rear emergency exit window labels are misplaced and incomplete, potentially delaying evacuation.
Forest River is recalling 2014-2016 Star Trans school buses because rear emergency exit window labels are misplaced and incomplete, potentially delaying evacuation.
Forest River is recalling certain 2021–2022 Puma travel trailers. The black wastewater-holding tank may lack ventilation, allowing methane gas to accumulate and increase fire risk.
Tiffin Motorhomes is recalling certain 2021-2022 Phaeton recreational vehicles due to an electrical outlet not properly installed during manufacturing, creating an open electrical wire inside the wall that could increase the risk of fire.
Joovy is recalling about 9,200 Zoom 360 Ultralight jogging strollers because the front wheel bearing can fail or detach, creating a fall hazard. The company is offering a free repair kit.