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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Halyard Medical Convenience Kits Recalled for Loose Metal Flakes

Agency Publication Date: November 14, 2024
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Summary

AVID Medical, Inc. has recalled 7,259 Halyard brand medical convenience kits due to the presence of loose metal flakes found on sponge forceps and towel clamps included in the packs. These metal flakes can detach from the surgical instruments and may enter a patient's surgical site during medical procedures. The recall involves a wide variety of specialized kits used for procedures such as biopsies, cardiac surgeries, and orthopedic treatments. There have been no reported incidents or injuries related to this issue to date.

Risk

Metal flakes that detach from surgical components and enter a surgical site undetected may cause local irritation or foreign body reactions in the patient. Because these kits are used in a variety of invasive procedures, the flakes pose a risk of being left inside the body.

What You Should Do

  1. This recall affects Halyard brand Medical Convenience Kits across multiple surgical specialties, including cardiac, orthopedic, gynecological, and general surgery packs.
  2. Identify if your kit is affected by checking the Model Number and Lot Number printed on the device label or outer packaging.
  3. See the Affected Products section below for the full list of affected codes.
  4. Stop using any kits identified as part of this recall immediately to prevent the risk of metal flake contamination during surgery.
  5. Contact AVID Medical, Inc. or your distributor to arrange for the return, replacement, or correction of the affected packs.
  6. For additional information, you may call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits
Model / REF:
AVMD018
Lot Numbers:
1600756
GTIN:
10809160304952

Recall #: Z-0383-2025; Quantity: 80 eaches

Product: Halyard IR BIOPSY PACK - Medical convenience kits
Model / REF:
AVMD019-01
Lot Numbers:
1583034
GTIN:
10809160304969

Recall #: Z-0384-2025; Quantity: 24 eaches

Product: Halyard D & C PACK-CKC - Medical convenience kits
Model / REF:
BMGT003-02
Lot Numbers:
1596759
GTIN:
10809160392027

Recall #: Z-0385-2025

Product: Halyard ENT T AND A PACK - Medical convenience kits
Model / REF:
EAMC106-02
Lot Numbers:
1591242
1600320
1604627
GTIN:
10809160308288

Recall #: Z-0386-2025; Quantity: 100 eaches

Product: Halyard OPEN HEART PACK MAIN - Medical convenience kits
Model / REF:
ESJH003-02
Lot Numbers:
1597931
GTIN:
10809160355725

Recall #: Z-0387-2025; Quantity: 114 eaches

Product: Halyard AORTA PACK - Medical convenience kits
Model / REF:
ESJH004-02
Lot Numbers:
1585536
GTIN:
10809160355770

Recall #: Z-0388-2025; Quantity: 36 eaches

Product: Halyard GENERAL SET UP PACK - Medical convenience kits
Model / REF:
ESJH005-02
Lot Numbers:
1583946
GTIN:
10809160400111

Recall #: Z-0389-2025; Quantity: 1,434 eaches

Product: Halyard KIT, TOTAL KNEE - Medical convenience kits
Model / REF:
ESJH012-07
Lot Numbers:
1606092
GTIN:
10809160421857

Recall #: Z-0390-2025; Quantity: 117 eaches

Product: Halyard KIT, SHOULDER - Medical convenience kits
Model / REF:
ESJH014-06
Lot Numbers:
1610214
GTIN:
10809160423226

Recall #: Z-0391-2025; Quantity: 42 eaches

Product: Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits
Model / REF:
ESJH017-03
Lot Numbers:
1600678
GTIN:
10809160406144

Recall #: Z-0392-2025; Quantity: 46 eaches

Product: Halyard ANTERIOR HIP PACK - Medical convenience kits
Model / REF:
EUOR001-06
Lot Numbers:
1610366
1610367
1610368
1610369
GTIN:
10809160423981

Recall #: Z-0393-2025; Quantity: 144 eaches

Product: Halyard KIT, TOTAL KNEE - Medical convenience kits
Model / REF:
EUOR002-05
Lot Numbers:
1604669
GTIN:
10809160412930

Recall #: Z-0394-2025; Quantity: 132 eaches

Product: Halyard KIT, TOTAL KNEE - Medical convenience kits
Model / REF:
EUOR002-06
Lot Numbers:
1611448
GTIN:
10809160426210

Recall #: Z-0395-2025; Quantity: 129 eaches

Product: Halyard KIT, SPINE - Medical convenience kits
Model / REF:
EUOR004-02
Lot Numbers:
1600550
GTIN:
10809160366479

Recall #: Z-0396-2025; Quantity: 165 eaches

Product: Halyard KIT, SPINE - Medical convenience kits
Model / REF:
EUOR004-03
Lot Numbers:
1597676
GTIN:
10809160426463

Recall #: Z-0397-2025; Quantity: 174 eaches

Product: Halyard FOOT ANKLE PACK - Medical convenience kits
Model / REF:
EUOR005-02
Lot Numbers:
1589794
GTIN:
10809160394595

Recall #: Z-0398-2025; Quantity: 72 eaches

Product: Halyard ABDOMINAL PROCEDURE - Medical convenience kits
Model / REF:
GRAN015-06
Lot Numbers:
1590888
GTIN:
10809160366707

Recall #: Z-0399-2025

Product: Halyard BASIC PROCEDURE PACK - Medical convenience kits
Model / REF:
GRAN019-06
Lot Numbers:
1587717
GTIN:
10809160365755

Recall #: Z-0400-2025; Quantity: 24 eaches

Product: Halyard TOTAL KNEE - Medical convenience kits
Model / REF:
GRND008-09
Lot Numbers:
1596070
GTIN:
10809160365779

Recall #: Z-0401-2025; Quantity: 60 eaches

Product: Halyard CYSTO PDS - Medical convenience kits
Model / REF:
GVVA002-05
Lot Numbers:
1597182
GTIN:
10809160398951

Recall #: Z-0402-2025; Quantity: 14 eaches

Product: Halyard MINOR PDS - Medical convenience kits
Model / REF:
GVVA009-06
Lot Numbers:
1592938
1594966
GTIN:
10809160393512

Recall #: Z-0403-2025; Quantity: 137 eaches

Product: Halyard LAPAROSCOPY TRAY - Medical convenience kits
Model / REF:
LANC006-25
Lot Numbers:
1603717
GTIN:
10809160368169

Recall #: Z-0404-2025; Quantity: 42 eaches

Product: Halyard GYN TRAY - Medical convenience kits
Model / REF:
LANC014-19
Lot Numbers:
1597709
GTIN:
10809160368237

Recall #: Z-0405-2025; Quantity: 136 units

Product: Halyard C SECTION BUNDLE - Medical convenience kits
Model / REF:
LANC015-34
Lot Numbers:
1590497
1601534
GTIN:
10809160380888

Recall #: Z-0406-2025; Quantity: 308 eaches

Product: Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits
Model / REF:
LANC022-29
Lot Numbers:
1594075
GTIN:
10809160368329

Recall #: Z-0407-2025; Quantity: 36 eaches

Product: Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits
Model / REF:
LANC026-19
Lot Numbers:
1588253
GTIN:
10809160368367

Recall #: Z-0408-2025; Quantity: 12 eaches

Product: Halyard TAH-BUNDLE - Medical convenience kits
Model / REF:
LANC039-29
Lot Numbers:
1596722
GTIN:
10809160368527

Recall #: Z-0409-2025; Quantity: 12 eaches

Product: Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits
Model / REF:
MAMC204-16
Lot Numbers:
1608931
GTIN:
10809160360767

Recall #: Z-0410-2025; Quantity: 22 eaches

Product: Halyard LINE INSERTION PACK - Medical convenience kits
Model / REF:
MAMC217-18
Lot Numbers:
1594486
1594624
GTIN:
10809160345658

Recall #: Z-0411-2025; Quantity: 30 eaches

Product: Halyard ANGIOGRAPHY PACK - Medical convenience kits
Model / REF:
MAMC218-18
Lot Numbers:
1591425
1597157
GTIN:
10809160316436

Recall #: Z-0412-2025

Product: Halyard PACEMAKER PACK - Medical convenience kits
Model / REF:
MAMC223-08
Lot Numbers:
1572713
GTIN:
10809160316481

Recall #: Z-0413-2025; Quantity: 12 eaches

Product: Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits
Model / REF:
MMCC004-01
Lot Numbers:
1605588
1605589
GTIN:
10809160421772

Recall #: Z-0414-2025; Quantity: 176 eaches

Product: Halyard ORTHO PACK - Medical convenience kits
Model / REF:
MMOK006-04
Lot Numbers:
1597105
1605626
GTIN:
10809160404201

Recall #: Z-0415-2025; Quantity: 44 eaches

Product: Halyard EXTREMITY PACK - Medical convenience kits
Model / REF:
MMOK009-03
Lot Numbers:
1589527
GTIN:
10809160404188

Recall #: Z-0416-2025; Quantity: 62 eaches

Product: Halyard MINOR PACK - Medical convenience kits
Model / REF:
MMOK013-03
Lot Numbers:
1598132
GTIN:
10809160411995

Recall #: Z-0417-2025

Product: Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits
Model / REF:
MSBM003-03
Lot Numbers:
1587478
GTIN:
10809160410172

Recall #: Z-0418-2025; Quantity: 411 eaches

Product: Halyard LOWER EXTREMITY PACK - Medical convenience kits
Model / REF:
PANJ001-03
Lot Numbers:
1608129
1608518
1610934
GTIN:
10809160321676

Recall #: Z-0419-2025; Quantity: 96 units

Product: Halyard UPPER EXTREMITY PACK - Medical convenience kits
Model / REF:
PANJ002-02
Lot Numbers:
1610935
1614208
GTIN:
10809160321683

Recall #: Z-0420-2025; Quantity: 96 eaches

Product: Halyard SHOULDER PACK - Medical convenience kits
Model / REF:
PANJ005
Lot Numbers:
1607501
1608148
1608519
GTIN:
10809160321706

Recall #: Z-0421-2025; Quantity: 96 eaches

Product: Halyard INTERVENTIONAL TRAY - Medical convenience kits
Model / REF:
PSSC004-03
Lot Numbers:
1608213
1610445
1611447
1615322
1619673
GTIN:
10809160348895

Recall #: Z-0422-2025; Quantity: 300 units

Product: Halyard LAPAROTOMY GYN PACK - Medical convenience kits
Model / REF:
SAMM018-13
Lot Numbers:
1589639
GTIN:
10809160410141

Recall #: Z-0423-2025; Quantity: 12 eaches

Product: Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits
Model / REF:
SAMM021-11
Lot Numbers:
1583045
GTIN:
10809160381991

Recall #: Z-0424-2025; Quantity: 14 eaches

Product: Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits
Model / REF:
SAMM023-13
Lot Numbers:
1595070
GTIN:
10809160382172

Recall #: Z-0425-2025; Quantity: 14 eaches

Product: Halyard ORAL SURGERY HEAD - Medical convenience kits
Model / REF:
SAMM029-15
Lot Numbers:
1595714
GTIN:
10809160382172

Recall #: Z-0426-2025; Quantity: 29 eaches

Product: Halyard OR ENDOVASCULAR TRAY - Medical convenience kits
Model / REF:
SAMM048-15
Lot Numbers:
1590860
1593416
GTIN:
10809160384206

Recall #: Z-0427-2025; Quantity: 24 eaches

Product: Halyard EYE PLASTIC TRAY - Medical convenience kits
Model / REF:
SAMM054-19
Lot Numbers:
1591258
GTIN:
10809160395189

Recall #: Z-0428-2025; Quantity: 14 eaches

Product: Halyard SAMMC-N PACEMAKER - Medical convenience kits
Model / REF:
SAMM065-10
Lot Numbers:
1586050
1586407
1605747
GTIN:
10809160370186

Recall #: Z-0429-2025; Quantity: 33 eaches

Product: Halyard SAMMC ANGIOGRAPHY - Medical convenience kits
Model / REF:
SAMM066-15
Lot Numbers:
1589652
1595715
GTIN:
10809160388495

Recall #: Z-0430-2025; Quantity: 216 eaches

Product: Halyard CPT CARDIAC CATH PACK - Medical convenience kits
Model / REF:
SHAN430-02
Lot Numbers:
1600943
1600944
1600945
GTIN:
10809160371800

Recall #: Z-0431-2025; Quantity: 288 eaches

Product: Halyard CPT PEDS ADULT CH PACK - Medical convenience kits
Model / REF:
SHAN431-06
Lot Numbers:
1599174
GTIN:
10809160417126

Recall #: Z-0432-2025; Quantity: 81 eaches

Product: Halyard CPT PEDS ADULT CH PACK - Medical convenience kits
Model / REF:
SHAN431-07
Lot Numbers:
1612993
GTIN:
10809160427224

Recall #: Z-0433-2025; Quantity: 42 eaches

Product: Halyard CPT EP PACK - Medical convenience kits
Model / REF:
SHAN442-04
Lot Numbers:
1608261
GTIN:
10809160413470

Recall #: Z-0434-2025; Quantity: 60 eaches

Product: Halyard C SECTION PACK - Medical convenience kits
Model / REF:
SJCS66-02
Lot Numbers:
1610500
GTIN:
10809160420072

Recall #: Z-0435-2025; Quantity: 20 eaches

Product: Halyard GYN PAC - Medical convenience kits
Model / REF:
SJGY20-02
Lot Numbers:
1604218
GTIN:
10809160420089

Recall #: Z-0436-2025; Quantity: 36 eaches

Product: Halyard CATH LAB PACK - Medical convenience kits
Model / REF:
VANW016-05
Lot Numbers:
1603736
GTIN:
10809160332719

Recall #: Z-0437-2025; Quantity: 42 eaches

Product: Halyard RAD PACK - Medical convenience kits
Model / REF:
VANW017-04
Lot Numbers:
1603839
GTIN:
10809160332733

Recall #: Z-0438-2025; Quantity: 44 eaches

Product: Halyard EP PACK - Medical convenience kits
Model / REF:
VANW018-06
Lot Numbers:
1598601
GTIN:
10809160401941

Recall #: Z-0439-2025; Quantity: 12 eaches

Product: Halyard BIOPSY PACK - Medical convenience kits
Model / REF:
VANW019-04
Lot Numbers:
1609032
GTIN:
10809160379462

Recall #: Z-0440-2025; Quantity: 88 eaches

Product: Halyard ANGIO TRAY - Medical convenience kits
Model / REF:
VAPX021-05
Lot Numbers:
1594310
1600532
GTIN:
10809160381243

Recall #: Z-0441-2025; Quantity: 138 eaches

Product: Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits
Model / REF:
VAPX040-01
Lot Numbers:
1590849
GTIN:
10809160360798

Recall #: Z-0442-2025; Quantity: 40 eaches

Product: Halyard PACEMAKER DRAPE - Medical convenience kits
Model / REF:
VAST020-06
Lot Numbers:
1588570
1596857
GTIN:
10809160333327

Recall #: Z-0443-2025; Quantity: 33 eaches

Product: Halyard IVR VASCULAR PACK - Medical convenience kits
Model / REF:
VAST027-08
Lot Numbers:
1608916
1608917
GTIN:
10809160416303

Recall #: Z-0444-2025; Quantity: 64 eaches

Product: Halyard SPECIALS PACK - Medical convenience kits
Model / REF:
VAST031-08
Lot Numbers:
1597663
GTIN:
10809160416310

Recall #: Z-0445-2025; Quantity: 45 eaches

Product: Halyard EP TRAY - Medical convenience kits
Model / REF:
VAST038-04
Lot Numbers:
1595421
GTIN:
10809160367995

Recall #: Z-0446-2025; Quantity: 0 eaches

Product: Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits
Model / REF:
VMCC021-06
Lot Numbers:
1572642
GTIN:
10809160334287

Recall #: Z-0447-2025; Quantity: 114 eaches

Product: Halyard MANIFOLD CATH PACK - Medical convenience kits
Model / REF:
VMED005-03
Lot Numbers:
1599372
1607988
GTIN:
10809160334904

Recall #: Z-0448-2025; Quantity: 232 eaches

Product: Halyard ENDOVASCULAR - Medical convenience kits
Model / REF:
VMED008-02
Lot Numbers:
1583502
1605477
GTIN:
10809160334935

Recall #: Z-0449-2025; Quantity: 24 eaches

Product: Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits
Model / REF:
VMED009-03
Lot Numbers:
1603129
1605478
GTIN:
10809160393918

Recall #: Z-0450-2025; Quantity: 24 eaches

Product: Halyard ENT - Medical convenience kits
Model / REF:
VMED011-01
Lot Numbers:
1582596
GTIN:
10809160334980

Recall #: Z-0451-2025; Quantity: 21 eaches

Product: Halyard PACK, MINOR - Medical convenience kits
Model / REF:
VMED018-02
Lot Numbers:
1581222
1588583
1592111
GTIN:
10809160335086

Recall #: Z-0452-2025; Quantity: 174 eaches

Product: Halyard PACEMAKER TRAY - Medical convenience kits
Model / REF:
VMPB0003-10
Lot Numbers:
1599244
GTIN:
10809160335536

Recall #: Z-0453-2025; Quantity: 6 eaches

Product: Halyard PACEMAKER PK - Medical convenience kits
Model / REF:
WKMC120-02
Lot Numbers:
1601647
GTIN:
10809160363638

Recall #: Z-0454-2025; Quantity: 56 eaches

Product: Halyard ANGIO PACK - Medical convenience kits
Model / REF:
WRNM047-05
Lot Numbers:
1585441
1602960
1606379
GTIN:
10809160374122

Recall #: Z-0455-2025; Quantity: 284 eaches

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95515
Status: Active
Manufacturer: AVID Medical, Inc.
Sold By: AVID Medical, Inc.; Halyard
Manufactured In: United States
Units Affected: 69 products (80 eaches; 24 eaches; 100 eaches; 114 eaches; 36 eaches; 1,434 eaches; 117 eaches; 42 eaches; 46 eaches; 144 eaches; 132 eaches; 129 eaches; 165 eaches; 174 eaches; 72 eaches; 24 eaches; 60 eaches; 14 eaches; 137 eaches; 42 eaches; 136 units; 308 eaches; 36 eaches; 12 eaches; 12 eaches; 22 eaches; 30 eaches; 12 eaches; 176 eaches; 44 eaches; 62 eaches; 411 eaches; 96 units; 96 eaches; 96 eaches; 300 units; 12 eaches; 14 eaches; 14 eaches; 29 eaches; 24 eaches; 14 eaches; 33 eaches; 216 eaches; 288 eaches; 81 eaches; 42 eaches; 60 eaches; 20 eaches; 36 eaches; 42 eahes; 44 eaches; 12 eaches; 88 eaches; 138 eaches; 40 eaches; 33 eaches; 64 eaches; 45 eaches; 0 eaches; 114 eaches; 232 eaches; 24 eaches; 24 eaches; 21 eaches; 174 eaches; 6 eaches; 56 eaches; 284 eaches)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.