Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
Ethicon, Inc. is recalling three units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.
Pentax of America Inc is recalling one unit of the EC38-i10L Video Colonoscope because it was distributed in the USA without an approved 510(k).
FDA is recalling Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23 due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Arrow International Inc. is recalling 205 units of the FlexTip Plus Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.
Abbott Point Of Care Inc. is recalling i-STAT CHEM8+ cartridges because they are not FDA cleared and do not have CLIA waived status.
Nobel Biocare is recalling 132 units of Abutment Screw Retrieval Instrument RP/WP/6.0 because a packaging sealing issue may compromise sterility during shelf life.
Arrow International Inc is recalling 2,126 units of STIM and INSL CPNB Tuohy needles because the product lidstock contains the incorrect expiration date.
Nobel Biocare is recalling 59 dental drills because a packaging defect may compromise sterility. The devices are distributed worldwide.
Arrow International Inc is recalling 1,760 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Enzymatic Creatinine reagent because phenindione therapy can cause falsely depressed results.
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Mindray is recalling 53 DP-30 ultrasound systems and 18 USB drives because the devices display an incorrect needle-guide bracket when used with a specific transducer.
Ormco/Sybronendo is recalling SnapLink brackets because the lower buccal tube slide doors may not stay closed, potentially causing tooth rotation and treatment delays.
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact sterility.
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Medicrea International is recalling 3 units of Universal Counter Torque for the Pass TULIP Spinal System because they are incompatible with the T30 nut driver.
Arrow International Inc. is recalling 540 units of the Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 because the product lidstock contains the incorrect expiration date.
Arrow International Inc. is recalling 870 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.
Suja Life LLC is recalling 8,798 bottles of Organic Tropical Dragon Fruit + Veggie Smoothie due to an unapproved herbicide in raw flax material.
Arrow International Inc. is recalling 410 units of Arrow PSI Kits due to incorrect expiration dates on the product lidstock.
Nobel Biocare is recalling specific dental drills because a packaging defect may compromise their sterility during shelf life.
Ethicon, Inc. is recalling 133 units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.
Arrow International Inc. is recalling 1,320 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.