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 3,434 eMax2 PLUS electric systems because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 14cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 455 units of 11cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
Breg Inc is recalling approximately 2,609 sterile dressings used with cold therapy pads because some may have unsealed pouches, rendering them non-sterile.
The Anspach Effort, Inc. is recalling eight Rotating Large Craniotomes because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 17 units of the 14CM Angle Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.
Sonesta Medical Ab is recalling 28 Sonesta S2 chairs because the user manual contains incorrect maximum patient weight information.
Terumo Medical Corporation is recalling Destination Renal Guiding Sheaths because the distal end may lack the labeled 5 cm of coating, potentially making device navigation difficult.
Perouse Medical is recalling 18,431 Dolphin Inflation Devices because of complaints regarding broken blisters. The devices were distributed in Arizona, Minnesota, and Tennessee.
The Anspach Effort, Inc. is recalling 90 degree Contra Angle Attachments because the supplied directions for use did not contain a recommended service interval.
Tradewind Foods is recalling Goya Octopus in Pickled Sauce because the product contains squid instead of octopus, as labeled.
The Anspach Effort, Inc. is recalling 121 Keyless Driver pneumatic systems because the supplied directions for use did not contain a recommended service interval.
P & L Development is recalling 369,012 cartons of diphenhydramine HCl allergy softgels sold under multiple brands due to low potency test results.
The Anspach Effort, Inc. is recalling 177 units of the 16cm Minimally Invasive Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 17 Autolube-III pneumatic systems because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 11.0cm Long Attachments for pneumatic systems because the supplied directions for use did not contain a recommended service interval.
Smith & Nephew is recalling 2017 units of Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.
The Anspach Effort, Inc. is recalling 51 units of the Autolube-III with Irrigation pneumatic system because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 8.0cm Medium Pneumatic System Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling five IMRI Short HD Pneumatic Attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 618 Minimal Access Attachment pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling Adult Craniotome Pneumatic Systems because the supplied Directions for Use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 130 units of 6.5cm Adult Cranial Thin Foot Plates because the supplied directions for use did not contain a recommended service interval.
Amneal Pharmaceuticals is recalling Rabeprazole Sodium Delayed Release Tablets, 20 mg, because the product failed to meet dissolution specifications.
Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.