Recall Register

Device recall: Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018

Class II FDA enforcement event 95515. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

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 20 Sep 2024. The firm address in the FDA record is in Toano, VA. FDA put the recall in Class II. FDA event 95515 has 73 product records. The first FDA enforcement report date is 20 Nov 2024. The record gives the status Ongoing.

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 . openFDA export of .

Distribution

In the words of FDA.

US Nationwide distribution.

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

73 product records in the event.

FDA event 95515: product records
Recall numberProductQuantityClassStatusReport date
Z-0383-2025Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD01880 eachesClass IIOngoing20 Nov 2024
Z-0384-2025Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-0124 eachesClass IIOngoing20 Nov 2024
Z-0385-2025Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02N/AClass IIOngoing20 Nov 2024
Z-0386-2025Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02100 eachesClass IIOngoing20 Nov 2024
Z-0387-2025Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02114 eachesClass IIOngoing20 Nov 2024
Z-0388-2025Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-0236 eachesClass IIOngoing20 Nov 2024
Z-0389-2025Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-021,434 eachesClass IIOngoing20 Nov 2024
Z-0390-2025Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07117 eachesClass IIOngoing20 Nov 2024
Z-0391-2025Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-0642 eachesClass IIOngoing20 Nov 2024
Z-0392-2025Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-0346 eachesClass IIOngoing20 Nov 2024
Z-0393-2025Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06144 eachesClass IIOngoing20 Nov 2024
Z-0394-2025Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05132 eachesClass IIOngoing20 Nov 2024
Z-0395-2025Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06129 eachesClass IIOngoing20 Nov 2024
Z-0396-2025Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02165 eachesClass IIOngoing20 Nov 2024
Z-0397-2025Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03174 eachesClass IIOngoing20 Nov 2024
Z-0398-2025Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-0272 eachesClass IIOngoing20 Nov 2024
Z-0399-2025Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06N/AClass IIOngoing20 Nov 2024
Z-0400-2025Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-0624 eachesClass IIOngoing20 Nov 2024
Z-0401-2025Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-0960 eachesClass IIOngoing20 Nov 2024
Z-0402-2025Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-0514 eachesClass IIOngoing20 Nov 2024
Z-0403-2025Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06137 eachesClass IIOngoing20 Nov 2024
Z-0404-2025Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-2542 eachesClass IIOngoing20 Nov 2024
Z-0405-2025Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19136 unitsClass IIOngoing20 Nov 2024
Z-0406-2025Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34308 eachesClass IIOngoing20 Nov 2024
Z-0407-2025Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-2936 eachesClass IIOngoing20 Nov 2024
Z-0408-2025Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-1912 eachesClass IIOngoing20 Nov 2024
Z-0409-2025Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-2912 eachesClass IIOngoing20 Nov 2024
Z-0410-2025Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-1622 eachesClass IIOngoing20 Nov 2024
Z-0411-2025Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-1830 eachesClass IIOngoing20 Nov 2024
Z-0412-2025Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18N/AClass IIOngoing20 Nov 2024
Z-0413-2025Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-0812 eachesClass IIOngoing20 Nov 2024
Z-0414-2025Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01176 eachesClass IIOngoing20 Nov 2024
Z-0415-2025Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-0444 eachesClass IIOngoing20 Nov 2024
Z-0416-2025Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-0362 eachesClass IIOngoing20 Nov 2024
Z-0417-2025Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03N/AClass IIOngoing20 Nov 2024
Z-0418-2025Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03411 eachesClass IIOngoing20 Nov 2024
Z-0419-2025Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-0396 unitsClass IIOngoing20 Nov 2024
Z-0420-2025Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-0296 eachesClass IIOngoing20 Nov 2024
Z-0421-2025Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ00596 eachesClass IIOngoing20 Nov 2024
Z-0422-2025Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03300 unitsClass IIOngoing20 Nov 2024
Z-0423-2025Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-1312 eachesClass IIOngoing20 Nov 2024
Z-0424-2025Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-1114 eachesClass IIOngoing20 Nov 2024
Z-0425-2025Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-1314 eachesClass IIOngoing20 Nov 2024
Z-0426-2025Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-1529 eachesClass IIOngoing20 Nov 2024
Z-0427-2025Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-1524 eachesClass IIOngoing20 Nov 2024
Z-0428-2025Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-1914 eachesClass IIOngoing20 Nov 2024
Z-0429-2025Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-1033 eachesClass IIOngoing20 Nov 2024
Z-0430-2025Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15216 eachesClass IIOngoing20 Nov 2024
Z-0431-2025Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02288 eachesClass IIOngoing20 Nov 2024
Z-0432-2025Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-0681 eachesClass IIOngoing20 Nov 2024
Z-0433-2025Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-0742 eachesClass IIOngoing20 Nov 2024
Z-0434-2025Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-0460 eachesClass IIOngoing20 Nov 2024
Z-0435-2025Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-0220 eachesClass IIOngoing20 Nov 2024
Z-0436-2025Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-0236 eachesClass IIOngoing20 Nov 2024
Z-0437-2025Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-0542 eahesClass IIOngoing20 Nov 2024
Z-0438-2025Halyard RAD PACK - Medical convenience kits Model Number: VANW017-0444 eachesClass IIOngoing20 Nov 2024
Z-0439-2025Halyard EP PACK - Medical convenience kits Model Number: VANW018-0612 eachesClass IIOngoing20 Nov 2024
Z-0440-2025Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-0488 eachesClass IIOngoing20 Nov 2024
Z-0441-2025Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05138 eachesClass IIOngoing20 Nov 2024
Z-0442-2025Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-0140 eachesClass IIOngoing20 Nov 2024

The table shows 60 of 73 product records. The FDA enforcement report lists all the records.

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 2024
970
Share of these events in Class II
87%
Product records in this event
73Median of the firm: 3
Events of the firm on the register
24

Other events of the firm

Official channels

Cite this page

Recall Register. FDA enforcement event 95515. https://recallregister.com/fda/ii/95515/. Source: openFDA enforcement reports. Data through .

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 Nationwide distribution.
What quantity of product is in FDA event 95515?
The event has 73 product records. The first record gives this quantity: 80 eaches
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?
87% of the 970 device events that started in 2024 are in Class II.