Recall archive

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

9 recalls · page 1 of 1

Medical devices

Reported Apr 27, 2022

Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

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

Resource Optimization & Innovation LLC

Matched: Brand — A kit component, the PDI Prevantics Swab, was recalled.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 5, 2020

regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating…

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

Resource Optimization & Innovation LLC

Matched: Brand — The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time…

FDA (openFDA device enforcement)

Medical devices

Reported Jun 24, 2020

Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used…

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

Resource Optimization & Innovation LLC

Matched: Brand — There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 29, 2017

Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical…

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

Resource Optimization & Innovation LLC

Matched: Brand · Reason for recall — Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF)…

FDA (openFDA device enforcement)

Medical devices

Reported Apr 5, 2017

Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland

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

Resource Optimization & Innovation LLC

Matched: Brand — Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a…

134 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 11, 2015

Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments…

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

Resource Optimization & Innovation LLC

Matched: Brand — The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.

FDA (openFDA device enforcement)

Medical devices

Reported Nov 4, 2015

Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.

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

Resource Optimization & Innovation LLC

Matched: Brand — Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially…

7 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 14, 2015

regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The…

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

Resource Optimization & Innovation LLC

Matched: Brand — The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

76 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 30, 2015

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.

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

Resource Optimization & Innovation LLC

Matched: Brand — Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

1 more product in this recall

FDA (openFDA device enforcement)

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