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Stop using now Medical device recall · FDA · Published September 20, 2024

AVID Medical Halyard Shoulder Kit Recall: Small Metal Flakes Risk Surgical Site Infection

AVID Medical recalls shoulder surgical kits with potential metal flakes causing surgical site reactions. Affected model ESJH014-06 may need replacement to prevent foreign body reactions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0391-2025Medical deviceAVID Medical ›
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Contact the company

Recalling firmAVID Medical, Inc.9000 Westmont Dr · Toano, VA 23168-9351
✎ GovInfoNow plain-language explainer

AVID Medical is recalling shoulder surgical kits that could have small metal flakes detach and enter surgical sites, potentially causing reactions or infections. This is serious because metal flakes might go unnoticed during surgery. Read more at govinfonow.com/recall/53895-avid-medical-halyard-shoulder-kit-recall-small-metal-flakes-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53895-avid-medical-halyard-shoulder-kit-recall-small-metal-flakes-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0391-2025

Cite this page

“AVID Medical Halyard Shoulder Kit Recall: Small Metal Flakes Risk Surgical Site Infection.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53895-avid-medical-halyard-shoulder-kit-recall-small-metal-flakes-risk. Based on FDA recall #Z-0391-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0391-2025%22&limit=1).

AVID Medical, Inc. voluntarily recalled Halyard KIT, SHOULDER medical convenience kits on Sept. 20, 2024, according to the FDA. The product may contain loose metal flakes that could detach and enter a patient's surgical site. Owners should contact AVID Medical for a refund.

How to tell if you have it

  • Brand: AVID Medical
  • Product: Halyard KIT, SHOULDER - Medical convenience kits
  • Model Number: ESJH014-06
  • UPC: 10809160423226
  • Lot Number: 1610214

The hazard

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

Context

GovInfoNow's records show AVID Medical, Inc. has 23 other recalls on record since June 22, 2017. Other recent recalls of similar products include Medline Convenience Kits Recall (July 10, 2026), Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), and Medline Medical Kits Recall (March 24, 2026).

How to tell if you have this one

Check for the model number ESJH014-06 on the kit. The kit was sold with lot number 1610214 and GTIN 10809160423226.

  • Brand
    AVID Medical
  • Product
    Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
  • Category
    Medical device
FDA recall event · 73 products

All 73 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-0383-2025Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018; GTIN: 10809160304952 Lot Number: 160075680 eaches
Z-0384-2025Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01; GTIN: 10809160304969 Lot Number: 158303424 eaches
Z-0385-2025Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02; GTIN: 10809160392027 Lot Number: 1596759N/A
Z-0386-2025Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02; GTIN: 10809160308288 Lot Number: 1591242, 1600320, 1604627100 eaches
Z-0387-2025Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02; GTIN: 10809160355725 Lot Number: 1597931114 eaches
Z-0388-2025Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02; GTIN: 10809160355770 Lot Number: 158553636 eaches
Z-0389-2025Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02; GTIN: 10809160400111 Lot Number: 15839461,434 eaches
Z-0390-2025Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07; GTIN: 10809160421857 Lot Number: 1606092117 eaches
Z-0391-2025Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06; GTIN: 10809160423226 Lot Number: 161021442 eaches
Z-0392-2025Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03; GTIN: 10809160406144 Lot Number: 160067846 eaches
Z-0393-2025Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06; GTIN: 10809160423981 Lot Number: 1610366, 1610367, 1610368, 1610369144 eaches
Z-0394-2025Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05; GTIN: 10809160412930 Lot Number: 1604669132 eaches
Z-0395-2025Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06; GTIN: 10809160426210 Lot Number: 1611448129 eaches
Z-0396-2025Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02; GTIN: 10809160366479 Lot Number: 1600550165 eaches
Z-0397-2025Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03; GTIN: 10809160426463 Lot Number: 1597676174 eaches
Z-0398-2025Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02; GTIN: 10809160394595 Lot Number: 158979472 eaches
Z-0399-2025Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06; GTIN: 10809160366707 Lot Number: 1590888N/A
Z-0400-2025Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06; GTIN: 10809160365755 Lot Number: 158771724 eaches
Z-0401-2025Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09; GTIN: 10809160365779 Lot Number: 159607060 eaches
Z-0402-2025Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05; GTIN: 10809160398951 Lot Number: 159718214 eaches
Z-0403-2025Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06; GTIN: 10809160393512 Lot Number: 1592938, 1594966137 eaches
Z-0404-2025Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25; GTIN: 10809160368169 Lot Number: 160371742 eaches
Z-0405-2025Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19; GTIN: 10809160368237 Lot Number: 1597709136 units
Z-0406-2025Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34; GTIN: 10809160380888 Lot Number: 1590497, 1601534308 eaches
Z-0407-2025Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29; GTIN: 10809160368329 Lot Number: 159407536 eaches
Z-0408-2025Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19; GTIN: 10809160368367 Lot Number: 158825312 eaches
Z-0409-2025Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29; GTIN: 10809160368527 Lot Number: 159672212 eaches
Z-0410-2025Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16; GTIN: 10809160360767 Lot Number: 160893122 eaches
Z-0411-2025Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18; GTIN: 10809160345658 Lot Number: 1594486, 159462430 eaches
Z-0412-2025Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18; GTIN: 10809160316436 Lot Number: 1591425, 1597157N/A
Z-0413-2025Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08; GTIN: 10809160316481 Lot Number: 157271312 eaches
Z-0414-2025Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01; GTIN: 10809160421772 Lot Number: 1605588, 1605589176 eaches
Z-0415-2025Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04; GTIN: 10809160404201 Lot Number: 1597105,160562644 eaches
Z-0416-2025Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03; GTIN: 10809160404188 Lot Number: 158952762 eaches
Z-0417-2025Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03; GTIN: 10809160411995 Lot Number: 1598132N/A
Z-0418-2025Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03; GTIN: 10809160410172 Lot Number: 1587478411 eaches
Z-0419-2025Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03; GTIN: 10809160321676 Lot Number: 1608129, 1608518, 161093496 units
Z-0420-2025Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02; GTIN: 10809160321683 Lot Number: 1610935, 161420896 eaches
Z-0421-2025Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005; GTIN: 10809160321706 Lot Number: 1607501, 1608148, 160851996 eaches
Z-0422-2025Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03; GTIN: 10809160348895 Lot Number: 1608213, 1610445, 1611447, 1615322, 1619673300 units
Z-0423-2025Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13; GTIN: 10809160410141 Lot Number: 158963912 eaches
Z-0424-2025Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11; GTIN: 10809160381991 Lot Number: 158304514 eaches
Z-0425-2025Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13; GTIN: 10809160382172 Lot Number: 159507014 eaches
Z-0426-2025Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15; GTIN: 10809160382172 Lot Number: 159571429 eaches
Z-0427-2025Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15; GTIN: 10809160384206 Lot Number: 1590860, 159341624 eaches
Z-0428-2025Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19; GTIN: 10809160395189 Lot Number: 159125814 eaches
Z-0429-2025Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10; GTIN: 10809160370186 Lot Number: 1586050, 1586407, 160574733 eaches
Z-0430-2025Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15; GTIN: 10809160388495 Lot Number: 1589652, 1595715216 eaches
Z-0431-2025Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02; GTIN: 10809160371800 Lot Number: 1600943, 1600944, 1600945288 eaches
Z-0432-2025Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06; GTIN: 10809160417126 Lot Number: 159917481 eaches
Z-0433-2025Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07; GTIN: 10809160427224 Lot Number: 161299342 eaches
Z-0434-2025Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04; GTIN: 10809160413470 Lot Number: 160826160 eaches
Z-0435-2025Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02; GTIN: 10809160420072 Lot Number: 161050020 eaches
Z-0436-2025Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02; GTIN: 10809160420089 Lot Number: 160421836 eaches
Z-0437-2025Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05; GTIN: 10809160332719 Lot Number: 160373642 eahes
Z-0438-2025Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04; GTIN: 10809160332733 Lot Number: 160383944 eaches
Z-0439-2025Halyard EP PACK - Medical convenience kits Model Number: VANW018-06; GTIN: 10809160401941 Lot Number: 159860112 eaches
Z-0440-2025Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04; GTIN: 10809160379462 Lot Number: 160903288 eaches
Z-0441-2025Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05; GTIN: 10809160381243 Lot Number: 1594310, 1600532138 eaches
Z-0442-2025Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01; GTIN: 10809160360798 Lot Number: 159084940 eaches
Z-0443-2025Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06; GTIN: 10809160333327 Lot Number: 1588570, 159685733 eaches
Z-0444-2025Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08; GTIN: 10809160416303 Lot Number: 1608916, 160891764 eaches
Z-0445-2025Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08; GTIN: 10809160416310 Lot Number: 159766345 eaches
Z-0446-2025Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04; GTIN: 10809160367995 Lot Number: 15954210 eaches
Z-0447-2025Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06; GTIN: 10809160334287 Lot Number: 1572642114 eaches
Z-0448-2025Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03; GTIN: 10809160334904 Lot Number: 1599372, 1607988232 eaches
Z-0449-2025Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02; GTIN: 10809160334935 Lot Number: 1583502, 160547724 eaches
Z-0450-2025Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03; GTIN: 10809160393918 Lot Number: 1603129, 160547824 eaches
Z-0451-2025Halyard ENT - Medical convenience kits Model Number: VMED011-01; GTIN: 10809160334980 Lot Number: 158259621 eaches
Z-0452-2025Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02; GTIN: 10809160335086 Lot Number: 1581222, 1588583, 1592111174 eaches
Z-0453-2025Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10; GTIN: 10809160335536 Lot Number: 15992446 eaches
Z-0454-2025Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02; GTIN: 10809160363638 Lot Number: 160164756 eaches
Z-0455-2025Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05; GTIN: 10809160374122 Lot Number: 1585441, 1602960, 1606379284 eaches
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Kit Immediately

    The recalled Halyard Shoulder Kit model ESJH014-06 should be stopped from use to prevent potential metal flakes from entering surgical sites.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Sep 20, 202412. FDA classified it Class II: Nov 14, 202423. Published in FDA’s Enforcement Report: Nov 20, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0391-2025 (September 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0391-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA