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Recall archive

94,355 stored notices, from Jun 20, 2012 to Sep 23, 2026.

22 recalls · page 1 of 1

Medical devices

Reported Sep 23, 2026

Halyard IV START KIT NON-STERILE REF: KRIV26-02

High riskUsing this product could cause serious injury, illness or death — stop using it now.

AVID Medical, Inc.

Matched: BrandConvenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides

FDA (weekly enforcement report)

Medical devices

Reported Sep 16, 2026

Halyard IV Start Kit Non-Sterile REF: KRIV26-02

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: BrandConvenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the…

FDA (weekly enforcement report)

Medical devices

Reported Sep 9, 2026Updated Sep 14, 2026

Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit)…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: Brand · Product · Product details · Reason for recallThe recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges…

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 2, 2026Updated Sep 7, 2026

Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: Brand · Reason for recallLabeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

6 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 26, 2026Updated Sep 7, 2026

Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: BrandThe kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a…

FDA (openFDA device enforcement)

Medical devices

Reported Aug 12, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

AVID Medical, Inc.

Matched: BrandAffected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates…

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jul 29, 2026

Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: Brand · Reason for recallIncorrect concentration of Betadine solution contained within certain AVID convenience kits.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 17, 2026

Halyard, Pain Pack. Kit Code: AMPK48-01.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: BrandInadvertent distribution of sealed pouches that had not undergone validated sterilization.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 13, 2026

Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

AVID Medical, Inc.

Matched: BrandPotential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…

9 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 18, 2026

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: BrandTyvek bag seal issue which may compromise sterility of the kit.

FDA (openFDA device enforcement)

Medical devices

Reported Jan 14, 2026

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

AVID Medical, Inc.

Matched: BrandDevices are not suitable for organ transplant.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 24, 2025

Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: BrandPotential for incomplete seal on header bag.

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 17, 2025

Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: BrandPotential for open header bag seals, compromising sterility.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 13, 2025

LAPAROSCOPIC TRAY. Medical convenience kit.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: Brand · Product · Product detailsCLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

23 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 21, 2025

Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: BrandAn issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle…

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 20, 2024

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AVID Medical, Inc.

Matched: Brand · Product · Product detailsSponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may…

72 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 16, 2021

ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Avid Medical, Inc.

Matched: Brand · Product · Product details · Reason for recallMedical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.…

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 25, 2020

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Avid Medical, Inc.

Matched: Brand · Product · Product details · Reason for recallThe medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper…

8 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 7, 2018

AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Avid Medical, Inc.

Matched: Brand · Product · Product detailsCertain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material…

22 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 21, 2018

AVID Medical QA Pack AV10654-10

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Avid Medical, Inc.

Matched: Brand · Product · Product detailsThe swab stick collection device provided in a convenience kit expires prior to the kit expiration date.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 26, 2017

Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Avid Medical, Inc.

Matched: Brand · Reason for recallAvid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was…

FDA (openFDA device enforcement)

Medical devices

Reported Aug 24, 2016

Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Avid Medical, Inc.

Matched: Brand · Reason for recallAvid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits…

3 more products in this recall

FDA (openFDA device enforcement)

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