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.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0383-2025 | Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018 | 80 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0384-2025 | Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01 | 24 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0385-2025 | Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02 | N/A | Class II | Ongoing | 20 Nov 2024 |
| Z-0386-2025 | Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02 | 100 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0387-2025 | Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02 | 114 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0388-2025 | Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02 | 36 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0389-2025 | Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02 | 1,434 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0390-2025 | Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07 | 117 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0391-2025 | Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06 | 42 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0392-2025 | Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03 | 46 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0393-2025 | Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06 | 144 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0394-2025 | Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05 | 132 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0395-2025 | Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06 | 129 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0396-2025 | Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02 | 165 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0397-2025 | Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03 | 174 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0398-2025 | Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02 | 72 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0399-2025 | Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06 | N/A | Class II | Ongoing | 20 Nov 2024 |
| Z-0400-2025 | Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06 | 24 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0401-2025 | Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09 | 60 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0402-2025 | Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05 | 14 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0403-2025 | Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06 | 137 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0404-2025 | Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25 | 42 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0405-2025 | Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19 | 136 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0406-2025 | Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34 | 308 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0407-2025 | Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29 | 36 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0408-2025 | Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19 | 12 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0409-2025 | Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29 | 12 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0410-2025 | Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16 | 22 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0411-2025 | Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18 | 30 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0412-2025 | Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18 | N/A | Class II | Ongoing | 20 Nov 2024 |
| Z-0413-2025 | Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08 | 12 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0414-2025 | Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01 | 176 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0415-2025 | Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04 | 44 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0416-2025 | Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03 | 62 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0417-2025 | Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03 | N/A | Class II | Ongoing | 20 Nov 2024 |
| Z-0418-2025 | Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03 | 411 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0419-2025 | Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03 | 96 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0420-2025 | Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02 | 96 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0421-2025 | Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005 | 96 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0422-2025 | Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03 | 300 units | Class II | Ongoing | 20 Nov 2024 |
| Z-0423-2025 | Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13 | 12 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0424-2025 | Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11 | 14 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0425-2025 | Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13 | 14 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0426-2025 | Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15 | 29 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0427-2025 | Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15 | 24 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0428-2025 | Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19 | 14 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0429-2025 | Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10 | 33 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0430-2025 | Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15 | 216 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0431-2025 | Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02 | 288 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0432-2025 | Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06 | 81 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0433-2025 | Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07 | 42 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0434-2025 | Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04 | 60 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0435-2025 | Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02 | 20 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0436-2025 | Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02 | 36 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0437-2025 | Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05 | 42 eahes | Class II | Ongoing | 20 Nov 2024 |
| Z-0438-2025 | Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04 | 44 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0439-2025 | Halyard EP PACK - Medical convenience kits Model Number: VANW018-06 | 12 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0440-2025 | Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04 | 88 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0441-2025 | Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05 | 138 eaches | Class II | Ongoing | 20 Nov 2024 |
| Z-0442-2025 | Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01 | 40 eaches | Class II | Ongoing | 20 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
- FDA enforcement report Z-0383-2025The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
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.