Freudenberg Medical, Llc recalls
Every recall we track for Freudenberg Medical, Llc — 4 in all, from 2022–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
4 recalls since 2017.
All FDA recall records for Freudenberg Medical, Llc 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 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 1 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 2 | 0 | 2 |
What to do if you have a recalled Freudenberg Medical, Llc 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 Freudenberg Medical, Llc recalls
2 shown- Lower riskMedical device
Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Freudenberg Medical recalls Blom-Singer Classic Indwelling Voice Prosthesis (16Fr/10 mm REF: 1610-LF) due to incorrect labeling that could lead to improper use. Affected units have specific lot numbers and UDI codes.
Freudenberg MedicalJun 17, 2026 - UnratedMedical device
Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Freudenberg Medical recalls Empower Introducer Sheath Model 668782-100 (US) due to potential embolism from non-intended glue in the catheter shaft. Affected units have specific lot numbers and UDI.
Freudenberg MedicalFeb 21, 2022
Freudenberg Medical, Llc recall questions
How many recalls has Freudenberg Medical, Llc had?
4 recalls from Freudenberg Medical, Llc are on record with U.S. safety agencies, from 2022–2026.
What is the most recent Freudenberg Medical, Llc recall?
Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF, dated Jun 17, 2026. Every Freudenberg Medical, Llc recall is listed on this page, newest first.
What should I do if I have a recalled Freudenberg Medical, Llc 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 Freudenberg Medical, Llc 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.