AVID Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
167 (17 Class I)
510(k) Clearances
2
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2410-2026Class IIHalyard, Eye Bag Pack. Kit Code: UIEB48-01.April 30, 2026
Z-2409-2026Class IIHalyard, Drape Pack. Kit Code: LMDP36-01.April 30, 2026
Z-2407-2026Class IIHalyard, Pain Pack. Kit Code: AMPK48-01.April 30, 2026
Z-2408-2026Class IIHalyard, Towel Six Pack. Kit Code: AMTS70-01.April 30, 2026
Z-1972-2026Class IHalyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.March 13, 2026
Z-1978-2026Class IHalyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.March 13, 2026
Z-1971-2026Class IHalyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.March 13, 2026
Z-1975-2026Class IHalyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.March 13, 2026
Z-1970-2026Class IHalyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.March 13, 2026
Z-1974-2026Class IHalyard CATH LAB kit. Model Number: SACL75-01.March 13, 2026
Z-1979-2026Class IHalyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.March 13, 2026
Z-1973-2026Class IHalyard CATH LAB kit. Model Number: SACL75AM.March 13, 2026
Z-1976-2026Class IHalyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.March 13, 2026
Z-1977-2026Class IHalyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.March 13, 2026
Z-1338-2026Class IIHalyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.January 2, 2026
Z-0928-2026Class IIHalyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.November 14, 2025
Z-0926-2026Class IIHalyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.November 14, 2025
Z-0930-2026Class IIHalyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.November 14, 2025
Z-0927-2026Class IIHalyard, EP LAB PK. Catalog Number: ESJH009-03.November 14, 2025
Z-0929-2026Class IIHalyard, MAJOR PACK. Catalog Number: JEMJ10-01.November 14, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K001731AVID-NIT LOSS OF RESISTANCE SYRINGEAugust 29, 2000
K000117AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLEApril 13, 2000