Monthly recall archive

U.S. Recalls — November 2025

Complete FDA and NHTSA recall records dated in November 2025.

326recall records
4categories
Nov 5, 2025first record date
Nov 26, 2025latest record date

November 2025 recalls — page 8

These records include useful source details for the selected month.

2025 archive →
Medical DeviceNov 12, 2025

Sentinel V11 recall — FDA Z-0416-2026

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG…

Class IIFDA: OngoingSpacelabs Healthcare, Ltd.
Medical DeviceNov 12, 2025

Osstem Dental X-Ray System T2Plus recall — FDA Z-0315-2026

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement…

Class IIFDA: OngoingOSSTEM Implant Co., Ltd.
Medical DeviceNov 12, 2025

Klassic BiPolar Head recall — FDA Z-0432-2026

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Class IIFDA: OngoingTotal Joint Orthopedics, Inc.
Medical DeviceNov 12, 2025

Osstem Dental X-Ray System T1 recall — FDA Z-0313-2026

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement…

Class IIFDA: OngoingOSSTEM Implant Co., Ltd.

How to use this monthly recall archive

Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.