OTC medicines: FDA Approvals, Recalls, 510(k) Clearances and Side…

41device recalls (since 1 Jan 2023)
28510(k) clearances (since 1 Jan 2023)

Each number has its full source under its own list below.

Device recalls

41 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

2Sep2026
Dressing, Compression
Reason: Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and inf…
Z-0081-2027
2Apr2026
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Reason: The devices were distributed without required FDA premarket clearance or approval.
Z-2082-2026
6Feb2026
System, Test, Blood Glucose, Over The Counter
Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 er…
Z-1545-2026
6Feb2026
System, Test, Blood Glucose, Over The Counter
Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 er…
Z-1546-2026
6Feb2026
System, Test, Blood Glucose, Over The Counter
Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 er…
Z-1547-2026
6Feb2026
System, Test, Blood Glucose, Over The Counter
Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 er…
Z-1548-2026
26Dec2025
Kit, Test, Pregnancy, Hcg, Over The Counter
Reason: Potential exposure of rodents and rodent activity in the distribution center.
Z-1184-2026
22Nov2025
Test, Luteinizing Hormone (Lh), Over The Counter
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate d…
Z-1259-2026
22Nov2025
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate d…
Z-1260-2026
3Nov2025
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Reason: Distribution without premarket approval/clearance.
Z-0744-2026