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.
Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.
FDA is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Justright Surgical is recalling JustRight 5mm Staplers because they may deliver incomplete staple formation and incomplete tissue closure.
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.
FDA Class II recall of Palindrome SI Chronic Catheter Kits by Covidien LLC because the devices may not meet antimicrobial specifications.
FDA Class II recall of Palindrome Precision SI Chronic Catheter Kits due to potential failure to meet antimicrobial specifications.
Medtronic Navigation is correcting 15,798 Navigated Cannulated Taps distributed worldwide due to a potential for injury during the cleaning process.
GE Healthcare is recalling six Innova IGS 540 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
Hamilton Medical is recalling Infant Flow Sensors because they may provide inaccurate flow measurements, causing ventilators to decrease ventilation in specific modes.
The FDA is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
GE Healthcare is recalling 10 Innova IGS 520 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
GE Healthcare is recalling three Innova IGS 620 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.
Zimmer, Inc. is recalling 352 Natural Knee II Revision Femoral Stems because a breach in the sterile barrier could lead to periprosthetic infection.
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units distributed worldwide with expiry dates of February 2018 and earlier.
Abbott Laboratories is recalling ICT Serum Calibrator REF 146-03 because it may generate lower than expected Potassium results on the Abbott Architect cSystem.
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling specific lots of Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Roche Diagnostics is recalling Creatinine Plus reagents because acetaminophen and N-acetylcysteine may cause falsely decreased test results.
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.