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Medical device recalls: August 2022

The FDA posted 98 medical device recall records in August 2022, from 16 recall events by 15 companies. 9 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

  1. GE Healthcare, LLC · 2 events, 2 records
  2. Mckesson Medical-Surgical Inc. Corporate Office · 1 event, 55 records
  3. Family Dollar Stores, Llc. · 1 event, 22 records
  4. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 1 event, 6 records, 6 Class I
  5. Siemens Medical Solutions USA, Inc · 1 event, 3 records
  6. Baxter Healthcare Corporation · 1 event, 1 record
  7. Boston Scientific Corporation · 1 event, 1 record
  8. Heartware, Inc. · 1 event, 1 record, 1 Class I

FDA root cause

  1. Environmental control · 55
  2. Storage · 22
  3. Device Design · 10
  4. Under Investigation by firm · 3
  5. Process control · 3
  6. Process design · 2
  7. Process change control · 1
  8. Nonconforming Material/Component · 1

Class I recalls (9)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (89)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.