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.
DeRoyal is recalling 144 shoulder arthroscopy procedure packs that contain recalled 3M Health Care Steri Drapes. The packs were distributed across 23 U.S. states.
ConMed's electrosurgical suction coagulator devices may have blocked suction ports that prevent proper function during procedures. Affected devices could cause procedure delays and require alternative equipment.
DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple U.S. states.
OurPharma LLC is recalling 691 fentanyl citrate injection cassettes due to underfilled units. The recall affects lots distributed in Missouri with expiration dates between December 2022 and January 2023.
Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.
DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.
Cordis angiographic catheter extensions may experience separation at the male connector during use. Approximately 2,915 US units were distributed; users should verify affected lot numbers.
Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.
Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.
Stradis Medical is recalling surgical procedure kits with potentially incomplete outer bag seals that may compromise sterility. The recall affects 35 units distributed nationwide in the US and Canada.
DeRoyal procedure packs distributed across multiple U.S. states are being recalled because they contain previously recalled 3M Steri Drapes. Affected healthcare facilities should stop using the packs and contact the manufacturer.
DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.
The FDA has issued a recall of 50 kits of DeRoyal BASIC EYE PACK, a medical device distributed across 23 U.S. states. The specific reason for the recall is not provided in available source information.
The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.
DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.
Stradis Medical is recalling 80 Henry Schein single-shot epidural kits due to potentially incomplete outer bag sealing that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.
Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.
DeRoyal is recalling 63 ACDF surgical implant kits distributed to 23 US states. This is a voluntary, Class II recall announced November 2022, with no reported illnesses or injuries.
Stradis Healthcare is recalling dental implant trays with incomplete outer bag seals that may compromise sterility. Affected units were distributed in the US and Canada.
Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.
DeRoyal procedure kits for spinal fusion are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by 3M. The affected 16 kits were distributed to healthcare facilities in 23 US states.
Stradis Medical recalls surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. The affected products were distributed nationwide in the US and Canada.
Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.
DeRoyal Industries is recalling 16 units of the DeRoyal CRANI PACK (Lot 56705261, expiring 6/1/2025) distributed across multiple U.S. states. The specific reason for this Class II recall is not disclosed in the source notice.