Recall classifications

PTCB PTCE
Patient Safety and Quality Assurance
Matrix
Difficulty 3 of 5

Question

A pharmacy technician is sorting fictional recall notices for a quality meeting. Match each described hazard with its FDA recall class.

Row	Class I	Class II	Class III
Reasonable probability of serious harm or death	✓ Correct	Not correct	Not correct
Temporary or medically reversible harm may occur; serious harm is remote	Not correct	✓ Correct	Not correct
Adverse health consequences are not likely	Not correct	Not correct	✓ Correct

Answer

Reasonable probability of serious harm or death: Class I · Temporary or medically reversible harm may occur; serious harm is remote: Class II · Adverse health consequences are not likely: Class III

Rationale

Class I describes the most serious hazard in this set. Class II includes temporary or reversible effects or a remote chance of serious harm; Class III applies when harm is unlikely.

RememberRecall classes distinguish the degree of health hazard.

Sources

Recalls and Shortages Branch U.S. Food and Drug Administration · License: US government work (public domain) · Retrieved November 4, 2026 · Recalls and Shortages Branch · page updated Thu, 08/11

Last verified: November 5, 2026 2 independent automated checks Question ptcb-psqa-00015, version 1

Checks are automated. No licensed clinician has reviewed this question. Check the sources and your program’s materials.

Report an error in this question. For education only; not medical advice. See all sources and licenses.