Spectra Medical Devices recalls

Spectra Medical Devices has 2 recalls on record with the FDA and USDA, the earliest in 2026 and the latest reported on 19 Aug 2026. 2 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is sterility.

Total recalls2since 2026

Last 12 months2reported

Class I150% of total

Ongoing2latest 19 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 1 0Jul 1 0

Severity split

Class I 1 50%Class II 1 50%Class III 0 0%

Why spectra medical devices is recalled

Sterility150%
Foreign Material150%

Product types

Pain Medication150%
Heart & Vascular Devices150%

By year

20262100%

Ongoing spectra medical devices recalls

2 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS I	Elevaris Sodium Chloride Injection, 9%, USP Ampule recalled	Spectra Medical Devices	Foreign Material	6 states
10 Jun 2026Drug	CLASS II	Lidocaine HCl Injection USP, mL, Single-Dose Ampules recalledLidocaine Hydrochloride	Spectra Medical Devices	Sterility	Nationwide

All spectra medical devices recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS I	Elevaris Sodium Chloride Injection, 9%, USP Ampule recalled	Spectra Medical Devices	Foreign Material	6 states
10 Jun 2026Drug	CLASS II	Lidocaine HCl Injection USP, mL, Single-Dose Ampules recalledLidocaine Hydrochloride	Spectra Medical Devices	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.