Fenwal Inc recalls
Every recall we track for Fenwal Inc — 9 in all, from 2019–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Fenwal Inc peaked in 2019 (4); 9 since 2017.
All FDA recall records for Fenwal Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 2 | 2 | 0 | 4 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 3 | 0 | 0 | 3 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 1 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Fenwal Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Fenwal Inc recalls
5 shown- Lower riskMedical device
Fenwal Inc recalls Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Fenwal recalls Amicus Exchange Kit Therapeutics due to potential stress leaks in centrifuge packs for certain batch numbers. Affected units may require replacement to prevent equipment damage.
FenwalFeb 14, 2023 - Use cautionMedical device
Fenwal Inc recalls Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Fenwal recalls Amicus Exchange Kits with leaking centrifuge packs that could cause blood leaks during blood component collection procedures. Affected kits have specific batch numbers and expiration dates.
FenwalFeb 25, 2021 - Lower riskMedical device
Fenwal Inc recalls Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error
Fenwal recalls Vigilant Drug Lib software versions 1.0 and 1.1 due to potential dose errors in patient medication administration. This software works with Volumat MC Agilia infusion pumps to reduce errors but requires specific patient weight ranges.
FenwalJun 24, 2019 - Use cautionMedical device
Fenwal Inc recalls Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and
Fenwal recalls CATSmart Continuous autotransfusion systems with specific model numbers and serial ranges due to risk of centrifuge tubing puncture during surgery.
FenwalMar 5, 2019 - Use cautionMedical device
Fenwal Inc recalls Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the
Fenwal recalls CATSmart Vacuum Units with serial numbers starting 5VTA0180-7VTA0957 due to potential failure displaying 'Failure vacuum unit' message during use.
FenwalFeb 11, 2019
Fenwal Inc recall questions
How many recalls has Fenwal Inc had?
9 recalls from Fenwal Inc are on record with U.S. safety agencies, from 2019–2023.
What is the most recent Fenwal Inc recall?
Fenwal Inc recalls Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform, dated Feb 14, 2023. Every Fenwal Inc recall is listed on this page, newest first.
What should I do if I have a recalled Fenwal Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Fenwal Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.