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.
Boston Scientific is recalling 788 IceSeed 1.5 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
GA Health Company Limited is recalling 10,000 ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.
ConMed Corporation is recalling 95 Infinity ACL Tibial Tip Guides because the tips may be laterally misaligned, potentially affecting the accuracy of the guide system.
Boston Scientific is recalling 75 units of IceFORCE 2.1 CX Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Target is recalling approximately 299,000 Cloud Island infant rompers because snaps can break or detach, posing choking, laceration, and pinching hazards to children.
Boston Scientific is recalling 729 IceSphere 1.5 S 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button is reported sticky or broken, which may cause prolonged procedures.
GE Healthcare is recalling two Revolution CT ES units due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.
Boston Scientific is recalling 26 units of IceRod 1.5 Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 140 IceFORCE 2.1 CX Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 947 IceRod i-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 2,429 IceSphere 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 262 IceRod 1.5 i-Thaw Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
B Braun Medical is recalling 248 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.
Boston Scientific is recalling 92 units of IceSphere 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 64 IceRod Prostate Cryoablation Kits nationwide because of a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 261 IcePearl 2.1 CX L 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 85 IceFORCE 2.1 CX Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
Nova Ortho-Med is recalling Star 8 Rolling Walkers because the front fork may unscrew from the leg, creating instability and a risk of the fork falling off.
Zimmer Biomet is recalling 4,713 Spinal Rod Cutters because they may fracture during use. The devices were distributed domestically and internationally.
Boston Scientific is recalling 22,289 IceFORCE 2.1 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 740 IceFORCE 2.1 CX L 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
ICU Medical is recalling Spiros administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.