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Spectra Medical Devices, LlcFDAMed source confidence · 80%Jun 22, 2026, 6:17 PM UTC · 15d ago
Spectra Medical Devices, Llc — FDA Class II (D-0554-2026)
Case File
Spectra Medical Devices, LLC is recalling 210,625 ampules of a human prescription drug due to sterility concerns. The recall is classified as a Class I recall, indicating a serious risk. The affected products were distributed in the U.S.
•Spectra Medical Devices is recalling 210,625 ampules of a prescription drug.
•The recall is due to a lack of assurance of sterility.
•This is classified as a Class I recall, indicating serious risk.
•Patients should check their medicine cabinets for affected products.
Why This Matters
Patients using the affected drug should stop using it and consult their healthcare provider. The recall affects 210,625 ampules, posing serious health risks.