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.
Baxter is correcting a software error in Abacus 3.1 that may display protein levels 1,000 times lower than actual when using Clinimix 4.25110.
NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.
Bausch & Lomb is recalling 35,253 tubes of Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, due to crystal precipitate formation causing a gritty sensation in the eye.
The Anspach Effort, Inc. is recalling nine Custom eMax 2 Plus Motors because they were not manufactured consistently with Quality System requirements.
Varian Medical Systems is recalling ProBeam Proton Therapy Systems because the Treatment Control and Monitoring application may fail to send treatment history records to the ARIA database.
NxStage Medical is recalling dialysate sacks used in home dialysis systems because aluminum levels exceeded internal specifications.
The Anspach Effort, Inc. is recalling two eMax 2 Plus Hand Controls because they were not manufactured consistently with Quality System requirements.
Zimmer, Inc. is recalling 147 VerSys Hip System stems because supplier forgings failed routine material inspections.
Alere San Diego is recalling BNP calibrators because a Level 5 bottle contains Level 4 material, causing calibration failures.
Spacelabs Healthcare is recalling Qube Compact Monitors due to a potential loss of network connection when switching to the Qube Docking Station without powering down.
Bausch & Lomb is recalling Muro 128 ophthalmic ointment because crystals form in the product, causing a gritty feeling in the eye.
Philips is recalling 24 Ingenia 1.5T MRI systems because some units shipped between December 2013 and March 2014 were supplied with incorrect M10 nuts instead of A4 stainless steel nuts.
Philips Medical Systems is recalling 33 Ingenia 1.5T MRI systems because incorrect M10 nuts were installed on the rear cover set.
The Anspach Effort, Inc. is recalling 16 custom pneumatic motor devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 8 mm Coarse Headless Screws because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices, specifically arthroscopic suture anchor threaders, because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling six eMax 2 Modified Hand Control units because they were not manufactured consistently with Quality System requirements.
E. G. Emils & Sons is recalling Wegman's Organic Ham due to possible plastic contamination. No injuries have been reported.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Calibrator 1 because calibrator values were assigned using a reference method that was not fully validated.
Kerr Corporation is recalling one lot of Tytin Regular Set dental restorative material because it may set faster than specified in the Directions for Use.
Elekta, Inc. is recalling 224 iGUIDE Systems because a software bug prevents the system from logging off. The recall covers units distributed worldwide.
Elekta, Inc. is recalling MOSAIQ oncology software versions 1.40 through 2.50 because scrolling actions can unintentionally change direction selections.
Roche Diagnostics is recalling cobas 6000 analyzer filters that may cause discrepant results and system alarms.
Thorne Research is recalling Captomer capsules because they are marketed as dietary supplements but contain DMSA, an active drug ingredient, making them unapproved new drugs.
Kodiak Wild Alaska Seafood is recalling 25 lb vacuum-packed Pacific Cod fillets because the firm distributed frozen seafood without a required operating permit or HACCP controls.