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 three XMax Motor units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 40 units of 3mm Coarse Diamond Ball attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 21 eMax2 Lower Profile Foot Pedals because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 10 units of 8 mm Coarse Threaded Headless Bone Screws because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two custom extension bearing sleeves because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 10 units of the 2.37mm Spiral Drill because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two custom Sagittal microSaw Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling eMax2 Plus Hand Controls because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Circular ePLUS-FP devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Device Autolube III 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.
The Anspach Effort, Inc. is recalling Modified Arthroscopic Knotless Suture Anchor Deployment Tools because they were not manufactured consistently with Quality System requirements.
Integra LifeSciences is recalling 61 units of Accell Evo3C Demineralized Bone Matrix because they were incorrectly packaged in boxes for a different product, creating a risk of improper surgical use.
Teleflex Medical is recalling RUSCH LaserTube tracheal tubes because the label failed to print a specific caution statement regarding natural rubber latex.
The Anspach Effort, Inc. is recalling 20 Anspach Custom MCA5-1SD devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling four Custom Medium Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling custom shoulder implants because they were not manufactured consistently with Quality System requirements.
Philips is recalling 454 Brilliance CT Big Bore systems because internal testing found radio frequency emissions exceeded IEC 60601-1-2 standards.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
Princess House Inc. is recalling 11,912 sets of Marissa Collection Tangerine Appetizer Plates because they leach cadmium above acceptable levels.
Siemens is recalling 108 LANTIS linear accelerator systems because using the software with unvalidated operating systems can cause data corruption and incorrect treatment records.
NxStage Medical is recalling dialysate sacks used in dialysis systems because they contain aluminum levels exceeding internal specifications.
The Anspach Effort, Inc. is recalling 68 arthroscopic suture anchor assemblies because they were not manufactured consistently with Quality System requirements.
BioFire is recalling the FilmArray Blood Culture Identification Panel due to an increased risk of false positive results when used with specific blood culture bottles.
The Anspach Effort, Inc. is recalling 113 MRI fluted routers because they were not manufactured consistently with Quality System requirements.