The Recall Desk

Manufacturer

Spectra Medical Devices, Llc

2 recalls in our database name Spectra Medical Devices, Llc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2026-08-19

Of the 2 recalls from Spectra Medical Devices, Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • SevereFDA (Devices)·Z-2873-2026·2026-08-19

    Spectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns

    Spectra Medical Devices is recalling Sodium Chloride Injection ampules because manufacturing issues may have compromised sterility, posing a risk of infection or inflammation to patients.

    Product
    Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-0554-2026·2026-06-10

    Spectra lidocaine ampules recalled over lack of sterility assurance

    Lidocaine HCl Injection USP in 5 mL single-dose ampules distributed by Spectra Medical Devices is being recalled for lack of assurance of sterility. 210,625 ampules affected.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS)
    Category
    Drug
    Distribution
    Distributed nationwide