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.
Medline Bilateral Micro Vasectomy Reversal kits are being recalled because representative samples did not meet applicable catheter performance specifications. 588 units affected.
Aripiprazole Tablets USP 30 mg from Ajanta Pharma are being recalled after a bottle containing Voriconazole Tablets 50 mg was labelled and distributed as aripiprazole. 6,143 bottles affected.
Medline CV Draping/Basin procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,432 units are affected.
Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.
Medline Pelvic Lap Packs are being recalled because representative samples did not meet applicable catheter performance specifications. 20 units are affected.
ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 150 mm length, are being recalled because of the potential for overpressure alerts.
Medline procedure kits including the Bioburden Test Kit and Kit Uro Robot Cystectomy are being recalled because sample catheters did not meet performance specifications. 123,030 units affected.
Medline Oral Restoration procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications.
ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.
ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.
BD Connecta BD Luer-Lok 360 stopcocks, REF 394910, are being recalled because the Port C connection may over thread or spin rather than tightening securely. 2,465,500 units affected.
The iLet Bionic Pancreas is being recalled because a screen unlock failure can leave the user stuck on the Lock Screen, unable to change the cartridge or announce a meal.
HeartMate 11 Volt Lithium Ion Standalone Backup Batteries, model 106128, are being recalled due to 11 volt backup battery failures. Twelve units are affected.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.
Medline cardiac procedure kits including basic heart, cardiac surgery, carotid endarterectomy and ECMO packs are being recalled over catheter specification failures. 4,801 units affected.
HeartMate 3 Left Ventricular Assist System kits, model 106524US, are being recalled due to 11 volt backup battery failures. Four units are affected.
Medtronic O-arm O2 Imaging Systems are being recalled because an anomaly in the detector panel firmware may cause image artifacts. 589 units are affected.
Medline medical procedure kits including ECMO chest exploration, coronary artery bypass and D&C/cysto trays are being recalled because sample catheters did not meet performance specifications.
ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 891 packs, or 5,346 units, are affected.
Medline labour and delivery and vaginal procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 24,388 units affected.
Medline Laparoscopy Combined - No Ndl procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 72 units affected.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 14 Fr, are being recalled across all lots because samples did not meet performance specifications. 8,260 units affected.
Medline gynaecology procedure kits including basic GYN, D&C hysteroscopy and GYN laparoscopy packs are being recalled over catheter specification failures. 44,656 units affected.
Medline procedure kits labeled Dr Fernandez are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.
Medline gynaecology procedure packs including hysteroscopy, D&C and tubal ligation kits are being recalled because sample catheters did not meet performance specifications. 37,324 units affected.