Avid Medical, Inc.

FDA Regulatory Profile

Avid Medical, Inc. appears in FDA public data with 192 recalls — including 26 Class I (most serious) —, 2 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3153-2026, Class I) was initiated on Aug 10, 2026. Its most recent 510(k) clearance was granted on Aug 29, 2000.

Summary

Total Recalls
192 (26 Class I)
510(k) Clearances
2
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3153-2026Class IHaylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;Aug 10, 2026
Z-3152-2026Class IHaylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;Aug 10, 2026
Z-3154-2026Class IHaylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;Aug 10, 2026
Z-3151-2026Class IHaylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;Aug 10, 2026
Z-3261-2026Class IIHalyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL ApplicatorJul 22, 2026
Z-3194-2026Class IHalyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL ApplicatorJul 22, 2026
Z-3260-2026Class IIHalyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL ApplicatorJul 22, 2026
Z-3108-2026Class IHalyard IV START KIT NON-STERILE REF: KRIV26-02Jul 14, 2026
Z-3109-2026Class IIHalyard IV Start Kit Non-Sterile REF: KRIV26-02Jul 14, 2026
Z-2964-2026Class IIHalyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (530390Jul 10, 2026
Z-3005-2026Class IIBrand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Jul 9, 2026
Z-3011-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Jul 9, 2026
Z-3009-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Jul 9, 2026
Z-3006-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Jul 9, 2026
Z-3008-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Jul 9, 2026
Z-3007-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Jul 9, 2026
Z-3010-2026Class IIHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03Jul 9, 2026
Z-3045-2026Class II1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINMay 19, 2026
Z-3046-2026Class IIHalyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22May 19, 2026
Z-3044-2026Class IIHalyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT,May 19, 2026

Recent 510(k) Clearances

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