FDA · Class I · September 23, 2026

AVID Medical recall: Haylard and 3 more products

AVID Medical, Inc. is recalling Haylard and 3 more products because of a sterility problem – 1640 kits; 80 kits; 240 kits; 340 kits. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on August 10, 2026. Distributed in 4 states (Illinois, North Carolina, Virginia, Wyoming).

Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.

An FDA laboratory that tests medical devices
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
ProductHaylard and 3 more products
BrandAVID Medical
CompanyAVID Medical, Inc.
TypeMedical devices
ClassificationClass I
Recall dateAugust 10, 2026
Published by FDASeptember 23, 2026
Quantity1640 kits; 80 kits; 240 kits; 340 kits
Recall ID99758
As listed by FDA

Recalled products (4)

  1. Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
    FDA recall number
    Z-3151-2026
    Codes, lots and dates
    Model/Item Number (Kit): DPGE002-02; UDI-DI: 10809160410325; Kit Lots: 1641713, 1641714, 1659697, 1668209; Recalled Sodium Chloride Ampule Lot: AB4003;
    Quantity
    1640 kits
    Classification
    Class I
  2. Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
    FDA recall number
    Z-3152-2026
    Codes, lots and dates
    Model/Item Number (Kit): BMCN001-05; UDI-DI: 10809160455128; Kit Lots: 1703122, 1707656, 1708053; Recalled Sodium Chloride Ampule Lot: AB5002;
    Quantity
    80 kits
    Classification
    Class I
  3. Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
    FDA recall number
    Z-3153-2026
    Codes, lots and dates
    Model/Item Number (Kit): PM415; UDI-DI: 10809160322154; Kit Lots: 1652485, 1656642, 1667835, 1676219, 1682251, 1691940; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
    Quantity
    240 kits
    Classification
    Class I
  4. Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
    FDA recall number
    Z-3154-2026
    Codes, lots and dates
    Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
    Quantity
    340 kits
    Classification
    Class I
Exactly as the agency lists them

Identifiers and details

FDA event ID
99758
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Toano, VA, United States

Why it was recalled

The problem: a sterility problem.

The reason the FDA lists: “Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.”

Where it was sold

4 states: Illinois, North Carolina, Virginia, Wyoming. Distribution as the FDA records it: “Domestic: IL, NC, VA, WY;”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99758, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

Other AVID Medical recalls

DateRecallProblemAgency
Sep 30, 2026AVID Medical recall: Halyard IV START KIT NON-STERILEMedical devices · 288 kits (6 cases)Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminat…
Most serious
FDA
Class I
Sep 30, 2026AVID Medical recall: Halyard IV START KIT NON-STERILEMedical devices · 816 kits (17 cases); 192 kits (4 cases)Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an op…
Serious
FDA
Class II
Sep 23, 2026AVID Medical recall: Halyard IV START KIT NON-STERILE REF: KRIV26-02Medical devices · 288 unitsConvenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators whi…
Most serious
FDA
Class I
Sep 16, 2026AVID Medical recall: Halyard IV Start Kit Non-Sterile REF: KRIV26-02Medical devices · 98 Kitsa sterility problem
Serious
FDA
Class II
Sep 9, 2026AVID Medical recall: Halyard medical convenience kits labeled as: 1) ENT and 2 more productsMedical devices · 11763 kits; 16223 kits; 816 kitsa sterility problem
Serious
FDA
Class II
Sep 2, 2026AVID Medical recall: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK and 1 more productMedical devices · 45 kits; 63 kits; 78 kits; 120 Kits; 130 KITSLabeling Deficiency: The medical kit labeling fails to identify that the statlock componen…
Serious
FDA
Class II
Aug 26, 2026AVID Medical recall: Halyard LAVH PACKMedical devices · 40 packsThe kit component was subjected to EO sterilization, contrary to the manufacturer recommen…
Serious
FDA
Class II

All 8 AVID Medical recalls →

FAQ

About this recall

Is AVID Medical Haylard recalled?

Yes. AVID Medical, Inc. recalled it on August 10, 2026; FDA published it September 23, 2026 (Class I). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Because of a sterility problem. The reason given: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

In 4 states (Illinois, North Carolina, Virginia, Wyoming).

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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