Device recall: Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.

Class II FDA enforcement event 98045. Recall start date: 14 Nov 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Potential for incomplete seal on header bag.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

AVID Medical, Inc. started this device recall on 14 Nov 2025. The firm address in the FDA record is in Toano, VA. FDA put the recall in Class II. FDA event 98045 has 5 product records. The first FDA enforcement report date is 24 Dec 2025. The record gives the status Ongoing.

FDA enforcement report The 5 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US distribution to GA, IL, NE, MD.

Recalling firm

AVID Medical, Inc., Toano, VA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

5 product records in the event.

FDA event 98045: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0926-2026	Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.	42 units	Class II	Ongoing	24 Dec 2025
Z-0927-2026	Halyard, EP LAB PK. Catalog Number: ESJH009-03.	240 units	Class II	Ongoing	24 Dec 2025
Z-0928-2026	Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.	300 units	Class II	Ongoing	24 Dec 2025
Z-0929-2026	Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.	90 units	Class II	Ongoing	24 Dec 2025
Z-0930-2026	Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.	56 units	Class II	Ongoing	24 Dec 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2025: 945
Share of these events in Class II: 85%
Product records in this event: 5Median of the firm: 3
Events of the firm on the register: 24

Other events of the firm

Other FDA enforcement events of AVID Medical, Inc.
Initiated	Product (first record)	Type	Class	Records
10 Aug 2026	Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;	Device	Class I	4
14 Jul 2026	Halyard IV Start Kit Non-Sterile REF: KRIV26-02	Device	Class II	1
14 Jul 2026	Halyard IV START KIT NON-STERILE REF: KRIV26-02	Device	Class I	1
10 Jul 2026	Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).	Device	Class II	1
9 Jul 2026	Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: S	Device	Class II	7
19 May 2026	Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.	Device	Class II	1
19 May 2026	Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit)	Device	Class II	3
7 May 2026	Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.	Device	Class II	1
30 Apr 2026	Halyard, Pain Pack. Kit Code: AMPK48-01.	Device	Class II	4
30 Apr 2026	Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAM	Device	Class I	3

AVID Medical, Inc.: all 24 events

Official channels

FDA enforcement report Z-0926-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 98045. https://recallregister.com/fda/ii/98045/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US distribution to GA, IL, NE, MD.
What quantity of product is in FDA event 98045?: The event has 5 product records. The first record gives this quantity: 42 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?: 85% of the 945 device events that started in 2025 are in Class II.