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 recalls certain Guider Softip Guide Catheters with incorrect tip curve shapes that differ from labeled specifications. Approximately 8,475 units were distributed nationwide.
GE Venue Go ultrasound carts can develop internal tilt mechanism failure, causing the system to detach from the cart and fall. Some 5,986 devices are affected worldwide.
Central Admixture Pharmacy Services Inc is recalling 3,384 phenylephrine syringes due to lack of assurance of sterility. The product was distributed nationwide.
The Apical Coring Knife in HeartMate 3 Left Ventricular Assist System kits may be inadequately sharp, potentially extending surgical implantation time. Thoratec has distributed 2,681 affected units worldwide.
Boston Scientific Corporation is recalling 326 units of Guider Softip XF Guide Catheters due to certain lots being distributed with an incorrect tip curve shape that differs from the labeled specifications.
Zimmer Surgical is recalling dermatome blades that produce thin, non-uniform skin grafts during surgical use. The defect may require additional surgical harvests to adequately cover grafting sites.
Central Admixture Pharmacy Services is recalling 403 bags of fentanyl injection due to lack of sterility assurance. The affected lots were distributed nationwide.
Ortho-Clinical Diagnostics is recalling 9,860 Proboscis/Piston Assemblies for VITROS diagnostic systems manufactured April-December 2022 due to a manufacturing defect that may cause falsely elevated drug assay results and delayed patient test results.
AB Sciex has recalled 38 units of the 4500MD Triple Quad Mass Spectrometer nationwide due to a rare risk of flame and electrode ejection from solvent leaks combined with electrical discharge.
Olympus is recalling Veran endobronchial navigation systems due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence. Devices may malfunction or interfere with other medical equipment.
Olympus is recalling 522 units of Veran navigation system biopsy needles due to manufacturing defects and insufficient electromagnetic compatibility testing. Devices may not function properly in certain electromagnetic environments.
The Crooked Row kratom edible product is recalled because kratom is an unapproved food additive. Consumers who purchased this product should not use it.
Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.
Central Admixture Pharmacy Services Inc. is recalling fentanyl-bupivacaine injectable solution due to lack of sterility assurance. The recall affects 190 units (250 mL bags) distributed nationwide.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Iron_2 Reagents due to a potential positive bias in test results that could affect the accuracy of Quality Control and patient iron level measurements.
Boston Scientific is recalling certain lots of Guider Softip cardiac guide catheters because they were distributed with an incorrect tip curve shape that doesn't match the product label. Approximately 3,738 units were affected.
Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.
Real Intelligence CORI RI.KNEE v2.0 surgical planning software is being recalled due to a missing planning stage in cases with significant knee deformation. Affected units nationwide should not be used without verification.
Boston Scientific is recalling Guider Softip Guide Catheters from certain lots because the tip curve shape does not match the labeled specification. No illnesses or injuries have been reported.
Vive Organic is recalling its Detox + Immunity wellness shots for undeclared coconut allergen. The product was distributed to retailers across 16 U.S. states.
The LFS flat screen arm system with surgical lamp has a broken or missing stopper block that could allow the screen to rotate excessively, potentially causing the spring shaft to break and shear off.
The Fresh Chile Company is recalling Sweet & Spicy BBQ sauce due to an undeclared fish (anchovies) allergen on the label. Consumers with fish allergies may be at risk.
Boston Scientific is recalling 1,728 units of Guider Softip Guide Catheter 6F due to a manufacturing defect producing incorrect tip curve shapes differing from labeled specifications.
Tesla is recalling 54,676 Model X vehicles from 2021-2023 because the vehicle controller may fail to detect low brake fluid and not display a warning light, creating a crash risk. Tesla has released a free over-the-air software update to fix the issue.
Central Admixture Pharmacy Services has recalled approximately 398 HYDROmorphone in dextrose 5% injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider immediately.