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.
Ziehm Imaging Inc is recalling 103 Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component.
Biomet is recalling G7 Acetabular Screws because the labels incorrectly list the diameter as 10.5mm instead of the actual 6.5mm.
Integra LifeSciences is voluntarily recalling unexpired lots of HITHSP10 Cranial Access Kits because the labeling for included DuraPrep and Monocryl sutures does not align with the kit's intended use.
Abbott Vascular is recalling HT Connect Peripheral Guide Wires because a small number of devices show partial delamination of the PTFE coating.
SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. The recall covers nationwide distribution.
Ziehm Imaging Inc is recalling 27 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Ziehm Imaging Inc is recalling 54 Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Ortho-Clinical Diagnostics is recalling VITROS Anti-HBs Calibrators and Reagent Packs because they may produce false positive results.
Sequel Naturals is recalling nine lots of Vega All-In-One Nutritional Shake Berry due to trace amounts of chloramphenicol.
SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. These screws are used to secure anterior cervical plates.
SpineFrontier is recalling four PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.
Sequel Naturals is recalling nine lots of Vega One Starter Kit due to trace amounts of chloramphenicol.
Ziehm Imaging Inc is recalling 60 Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Lewis Bakeries is recalling 111,807 loaves of whole wheat bread nationwide because two small food-grade stainless steel fragments were found in two slices.
Sequel Naturals is recalling nine lots of Vega ONE Nutritional Shake Chocolate due to trace amounts of chloramphenicol.
Ziehm Imaging Inc is recalling one Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System because an engineering change made the emergency switch an optional component.
OrthoPediatrics Corp is recalling 40 ACL Sleeve Installation Tools that may be etched with the wrong size. The tools were shipped in November 2013.
CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.
Sequel Naturals is recalling nine lots of Vega Sport Performance Protein Powder due to trace contamination with chloramphenicol.
Sequel Naturals is recalling nine lots of Vega ONE Nutritional Shake French Vanilla due to trace amounts of chloramphenicol.
Data Innovations is recalling Instrument Manager driver software for the Sysmex UF-100 analyzer due to potential sample errors.
Airgas Medical Services is recalling 145 compressed oxygen cylinders that may be empty due to a manufacturing error. The cylinders were distributed to medical facilities in four states.
Ziehm Imaging Inc is recalling 58 Solo C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE Folic Acid kits due to a potential accelerated decline in counts that may cause failed adjustments before expiration.
SpineFrontier, Inc. is recalling 13 PedFuse Reset Screw Inserters because they may not mate properly with the hex interface of the screws.