PlainRecalls

Fenwal Inc

Compiled from official public sources by the publisher.

10 recalls on record · Latest: Mar 22, 2023

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Agency notice ledger

Federal filing book Fenwal Inc LIGHT-BOOK · SINGLE-AGENCY

#1,451 of 14,151 · 10 notices · 0.010% archive

  • BOOK 10 notices
  • RANK #1,451 of 14,151
  • SHARE 0.010% archive
  • AGENCY FDA Devices (10)
  • CAT medical devices
  • CATS 1 category
  • LATEST Mar 22, 2023
  • PHOTO 4 Earth Farms formerl…

Nearest notice-volume peer: 4 Earth Farms formerly Mcl Fresh Inc (0 notice gap)

Fenwal Inc accounts for about 0.010% of the 104,423-notice archive on 10 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Fenwal Inc compares to 14,151 recalling firms

Fenwal Inc ranks 1,451st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Fenwal Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

10 1451st of 14151 higher than 12,602 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-15

Fenwal Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Fenwal Inc holds about 0.010% of archive notices alongside 10 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Mar 22, 2023

Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
FDA Devices Moderate Mar 22, 2023

Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
FDA Devices Moderate Apr 14, 2021

Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Devices Moderate Apr 14, 2021

Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Devices Moderate Apr 14, 2021

Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Devices Critical Aug 21, 2019

Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the Volum
FDA Devices Critical Aug 21, 2019

VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, co
FDA Devices Moderate May 1, 2019

Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processi
FDA Devices Moderate Apr 3, 2019

Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
FDA Devices Moderate Jun 19, 2013

AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.

Fenwal Inc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Amerx Health Care Corp. 10 Bausch & Lomb Surgical, Inc. 10 Beekley Corporation 10 Biocare Medical, LLC 10

Frequently Asked Questions

How many federal recall notices name Fenwal Inc? ▼
PlainRecalls indexes 10 distinct federal recall events naming Fenwal Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Fenwal Inc sit among other recalling firms? ▼
Fenwal Inc ranks #1,451 of 14,151 by distinct recall-event count among 14,151 firms in this archive (89th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Fenwal Inc's notices? ▼
FDA Devices accounts for 10 of this firm's 10 indexed notices.
What product category dominates Fenwal Inc's filing book? ▼
Filings for Fenwal Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Fenwal Inc: 10 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Fenwal Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026