Spectra Medical Devices, Llc
FDA Regulatory Profile
Spectra Medical Devices, Llc appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 8 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2873-2026, Class I) was initiated on July 6, 2026. Its most recent 510(k) clearance was granted on September 8, 2017.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 8
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2873-2026 | Class I | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10m | July 6, 2026 |
| D-0554-2026 | Class II | Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical | May 12, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163292 | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford | September 8, 2017 |
| K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle | February 5, 2016 |
| K142791 | Spectra Soft Tissue Biopsy Needles | January 21, 2015 |
| K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE | July 29, 2011 |
| K082689 | STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE | March 20, 2009 |
| K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | December 8, 2008 |
| K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF | November 28, 2008 |
| K081524 | SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESIST | July 29, 2008 |