Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices inside the pouch.
Strides Pharma Inc. is recalling 960 bottles of 1mg Tacrolimus capsules due to failed moisture limits. The recall is limited to Pennsylvania.
US Compounding Inc is recalling 1,640 syringes of Neostigmine Methylsulfate Injection because they are missing labels. The product was distributed nationwide.
Applied Medical Technology Inc is recalling specific lots of ENFit-to-Stepped Male adapters because the inner pouches may have incorrect labels, although the outer boxes are correct.
SCA Pharmaceuticals is recalling specific lots of Fentanyl injection for IV or IM use because stability testing showed low potency.
Novocol Pharmaceutical is recalling 15,398 cartridges of Scandonest 3% Plain (Mepivacaine Hydrochloride) due to a label mix-up. The product is distributed nationwide.
Talladium Inc is recalling 10 units of Luminesse ML PMMA milling blanks due to incorrect labels that may cause compatibility issues with milling machines.
Teligent Pharma is recalling Clobetasol Propionate Ointment 0.05% because some tubes have superpotent or subpotent assay results.
InvaTech Pharma Solutions is recalling specific lots of Levocetirizine Dihydrochloride Tablets 5 mg because one lot failed stability testing.
Advanced Bionics is recalling 28 AB PowerCel 170 batteries due to mislabeling that may indicate incorrect battery life.
Steris Corporation is recalling Olympus Leak Test Adapters used with Acu-sInQ systems due to a potential for cleaning solution to intrude into endoscopes.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Performance Verifier II due to product instability that causes biased ALKP values.
Merz North America is recalling 2,051 units of COAPTITE Injectable Implant because the Instructions for Use do not match post-approval study data.
Micro-Tech USA is recalling Elastic Traction Devices because they are not appropriately classified as Class I and require 510(k) clearance.
Denali Ingredients LLC is recalling 2,250 lbs of Cream Tech 250 Sour Cream Stabilizer because it was made with citric acid instead of sodium citrate.
XTANT Medical is recalling 508 units of cervical implants because the labels incorrectly identify the grade of titanium used in the devices.
Hardy Diagnostics is recalling Strep B Carrot Broth One-Step units because the outer box displays an incorrect expiration date of 2021-11-10 instead of 2020-11-10.
Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'
Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' instead of a 'specially controlled medical device.'
Synthes (USA) Products LLC is recalling 23 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'
Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly stated 'general medical device' instead of 'specially controlled medical device'.
Synthes (USA) Products LLC is recalling 16 SynMesh Cages distributed in Japan because the statutory label incorrectly identified them as general medical devices.
Teligent Pharma is recalling Fluocinonide Ointment USP 0.05% due to out-of-specification impurity results.