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.
Philips is recalling 18 Ingenia 3.0T MRI systems because incorrect M10 nuts were used instead of stainless steel nuts.
The Anspach Effort, Inc. is recalling eMax2 Console units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 45 Anspach Custom XMax Pneumatic Motors because they were not manufactured consistently with Quality System requirements.
Philips is recalling 21 Ingenia 3.0T MRI systems because some were shipped with incorrect M10 nuts instead of A4 stainless steel nuts.
The Anspach Effort, Inc. is recalling 50 units of 5mm Coarse Diamond Ball devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Device SC2102 units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling specific custom medical devices because they were not manufactured consistently with Quality System requirements.
Siemens is recalling 76 RAD Fluoro Uro Systems because a software malfunction can cause images to appear very dark, potentially leading to unnecessary repeat examinations.
The Anspach Effort, Inc. is recalling Anspach Custom Autolube Food Guard devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling three eMax Hand Control units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
NxStage Medical is recalling 91 cases of dialysate sacks because aluminum levels exceeded internal specifications. The product was distributed in the US and internationally.
Ford is recalling 2014 Transit Connect vehicles because the brake reservoir cap may lack required text identifying the correct brake fluid. This non-compliance could lead to incorrect fluid usage and brake system damage.
The Anspach Effort, Inc. is recalling 130 units of 4mm Fluted Balls for MRI because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 100 units of Arthroscopic Knotless Suture Anchors because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Modified MDA Tubes with MA-D20 Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling three Custom QD11 Attachments because they were not manufactured consistently with Quality System requirements.
Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood test results.
The Anspach Effort, Inc. is recalling Knotless Suture Anchor Deployment Tools because the units and records were not consistent with Quality System requirements.
The Anspach Effort, Inc. is recalling 13 mm Drills with Depth Stops because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two Custom Device Speed Reducer units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling six Modified QD11 Attachments because they were not manufactured consistently with Quality System requirements.
LAP of America is recalling one Laser Pictor 3D system in North Carolina because the yellow projection line can split into red and green lines, causing a 2.5mm deviation.
The Anspach Effort, Inc. is recalling 20 units of 2mm Coarse Diamond Ball attachments because they were not manufactured consistently with Quality System requirements.