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.
The Anspach Effort, Inc. is recalling 128 Compact Speed Reducer units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 119 Otologic Curved Micro pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Harvard Drug Group is recalling 914 cartons of Fluconazole 200 mg tablets because they failed to meet required dissolution specifications.
The Anspach Effort, Inc. is recalling 247 pneumatic system attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 Oscillating MICRO-SAW pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 17 AL-III pneumatic hose units because the supplied directions for use did not contain a recommended service interval.
Smith & Nephew is recalling 1,126 units of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.
The Anspach Effort, Inc. is recalling Large Craniotome pneumatic systems because the supplied directions for use did not contain a recommended service interval.
Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the software's Export feature incorrectly handles Tetra Combo CRD files.
Breg Inc is recalling 2,609 units of Dressing Back P/N 09810 because approximately 0.22% may have unsealed pouches, rendering them non-sterile.
The Anspach Effort, Inc. is recalling 45 degree Contra Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 8.0CM Heavy Duty Medium Pneumatic Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling three IMRI Air Control pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling foot control irrigation systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 8CM Angle Attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 209 Electronic Foot Controls with Direction Switches because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 50 units of the SMALL ATTACHMENT, JACOBS CHUCK because the supplied directions for use did not contain a recommended service interval.
Boston Scientific is voluntarily removing three lots of JETSTREAM atherectomy catheters because some units were mislabeled with incorrect sizes.
The Anspach Effort, Inc. is recalling 568 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 158 eMax2 Motor Assemblies because the supplied directions for use did not include a recommended service interval.
Smith & Nephew is recalling 1,741 units of Renovation osteotome blades because stability data does not support the labeled 10-year shelf life.
The Anspach Effort, Inc. is recalling 679 Pediatric Craniotomes because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 112 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling Autolube-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 239 Autolube-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.