Description
FDA defines a device recall by regulation as a firm's removal or correction of a marketed device that the Agency considers to be in violation of the laws that it administers and against which the agency would initiate legal action, e.g., seizure. 21 CFR 7.3(g). The key factor in distinguishing a medical device recall from an enhancement is the existence of a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 360h] or associated regulations enforced by the Agency.
Scope & Applicability
Product Classes
3Where there is no generally accepted CM for an IVD device type
Used for patient management or selection in a clinical trial
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Stakeholders
2Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Identified Hazards
Hazards
2A software defect in infusion pumps leading to incorrect dosing.
A defect in guide wires attributed to steel quality.
Related CFR Sections (3)
- 21CFR801.5§ 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →
- 21CFR806.2§ 806.2 Definitions.
As used in this part:Read full regulation →
- 21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- CPG Sec. 396.400 Policy on Warned on Sunlamp Products (Status: Final)
- CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements (Status: Final)
- Policy on Warning Label Required on Sunlamp Products (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Guidance Document For Nonprescription Sunglasses - Guidance for Industry (Status: Final)
- Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers (Status: Final)
- Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA (Status: Final)
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration Staff (Status: Final)