FDA recall record · openFDA
AVID Medical, Inc.
125 FDA recalls on record (2024–2026) — 125 device. 125 still ongoing.
13
Class I (most serious)
112
Class II
0
Class III
125
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. M 73
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. 24
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or 10
Potential for incomplete seal on header bag. 5
Inadvertent distribution of sealed pouches that had not undergone validated sterilization. 4
Recalls
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. Class I 2026-03-13 Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. Class I 2026-03-13 Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. Class I 2026-03-13 Halyard CATH LAB kit. Model Number: SACL75-01. Class I 2026-03-13 Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. Class I 2026-03-13 Halyard CATH LAB kit. Model Number: SACL75AM. Class I 2026-03-13 Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. Class I 2026-03-13 Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. Class I 2026-03-13 Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. Class I 2026-03-13 Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. Class I 2026-03-13 Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. Class I 2025-11-11 Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. Class I 2025-11-11 Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 Class I 2025-11-11 Halyard, Towel Six Pack. Kit Code: AMTS70-01. Class II 2026-04-30 Halyard, Pain Pack. Kit Code: AMPK48-01. Class II 2026-04-30 Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. Class II 2026-01-02 Halyard, Drape Pack. Kit Code: LMDP36-01. Class II 2026-04-30 Halyard, Eye Bag Pack. Kit Code: UIEB48-01. Class II 2026-04-30 GYN ROBOTIC PACK. Medical convenience kit. Class II 2025-06-11 LAP CHOLE PACK. Medical convenience kit. Class II 2025-06-11 PACK GENERAL ROBOTIC. Medical convenience kit. Class II 2025-06-11 LAVH PACK. Medical convenience kit. Class II 2025-06-11 Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01. Class II 2025-11-14 LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit. Class II 2025-06-11 DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit. Class II 2025-06-11 PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit. Class II 2025-06-11 Halyard, EP LAB PK. Catalog Number: ESJH009-03. Class II 2025-11-14 LAPAROSCOPIC GYN. Medical convenience kit. Class II 2025-06-11 Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit Class II 2025-03-31 Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. Class II 2025-11-14 Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09. Class II 2025-11-14 LAPAROSCOPIC TRAY. Medical convenience kit. Class II 2025-06-11 ROBOTIC URO/GYN PACK. Medical convenience kit. Class II 2025-06-11 Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit. Class II 2025-03-31 Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. Class II 2025-08-04 GYN LAPAROSCOPY PACK. Medical convenience kit. Class II 2025-06-11 ROBOTIC PROSTATECTOMY PACK. Medical convenience kit. Class II 2025-06-11 GENERAL LAPAROSCOPY TRAY. Medical convenience kit. Class II 2025-06-11 GEN LAPAROSCOPY PACK. Medical convenience kit. Class II 2025-06-11 LAPAROSCOPY PACK. Medical convenience kit. Class II 2025-06-11 MAJOR THORACOSCOPY BASIN. Medical convenience kit. Class II 2025-06-11 PARTIAL NEPHRECTOMY PACK. Medical convenience kit. Class II 2025-06-11 HVI CARDIAC ROBOT PACK. Medical convenience kit. Class II 2025-06-11 GENERAL ROBOTIC PACK. Medical convenience kit. Class II 2025-06-11 Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit. Class II 2025-03-31 CARDIAC ROBOT PACK. Medical convenience kit. Class II 2025-06-11 DAVINCI UROLOGY. Medical convenience kit. Class II 2025-06-11 Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit. Class II 2025-08-04 GS ENDOSCOPY PACK. Medical convenience kit. Class II 2025-06-11 CT DAVINCI. Medical convenience kit. Class II 2025-06-11 Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10. Class II 2025-11-14 DA VINCI PACK URO/PROSTATE. Medical convenience kit. Class II 2025-06-11 Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06 Class II 2024-09-20 Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08 Class II 2024-09-20 Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03 Class II 2024-09-20 Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02 Class II 2024-09-20 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07 Class II 2024-09-20 Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02 Class II 2024-09-20 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05 Class II 2024-09-20 Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07 Class II 2024-09-20 Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15 Class II 2024-09-20 Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02 Class II 2024-09-20 Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03 Class II 2024-09-20 Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02 Class II 2024-09-20 Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05 Class II 2024-09-20 Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09 Class II 2024-09-20 Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04 Class II 2024-09-20 Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018 Class II 2024-09-20 Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02 Class II 2024-09-20 Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29 Class II 2024-09-20 Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08 Class II 2024-09-20 Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01 Class II 2024-09-20 Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03 Class II 2024-09-20 Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19 Class II 2024-09-20 Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19 Class II 2024-09-20 Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005 Class II 2024-09-20 Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02 Class II 2024-09-20 Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06 Class II 2024-09-20 Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18 Class II 2024-09-20 Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06 Class II 2024-09-20 Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15 Class II 2024-09-20 Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05 Class II 2024-09-20 Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29 Class II 2024-09-20 Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01 Class II 2024-09-20 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06 Class II 2024-09-20 Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03 Class II 2024-09-20 Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06 Class II 2024-09-20 Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02 Class II 2024-09-20 Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03 Class II 2024-09-20 Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10 Class II 2024-09-20 Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15 Class II 2024-09-20 Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16 Class II 2024-09-20 Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02 Class II 2024-09-20 Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02 Class II 2024-09-20 Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03 Class II 2024-09-20 Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05 Class II 2024-09-20 Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04 Class II 2024-09-20 Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03 Class II 2024-09-20 Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19 Class II 2024-09-20 Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02 Class II 2024-09-20 Halyard ENT - Medical convenience kits Model Number: VMED011-01 Class II 2024-09-20 Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04 Class II 2024-09-20 Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11 Class II 2024-09-20 Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02 Class II 2024-09-20 Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13 Class II 2024-09-20 Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04 Class II 2024-09-20 Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02 Class II 2024-09-20 Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06 Class II 2024-09-20 Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13 Class II 2024-09-20 Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06 Class II 2024-09-20 Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05 Class II 2024-09-20 Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03 Class II 2024-09-20 Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02 Class II 2024-09-20 Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01 Class II 2024-09-20 Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04 Class II 2024-09-20 Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08 Class II 2024-09-20 Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06 Class II 2024-09-20 Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18 Class II 2024-09-20 Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06 Class II 2024-09-20 Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10 Class II 2024-09-20 Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34 Class II 2024-09-20 Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03 Class II 2024-09-20 Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02 Class II 2024-09-20 Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25 Class II 2024-09-20 Halyard EP PACK - Medical convenience kits Model Number: VANW018-06 Class II 2024-09-20
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.