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Medical device recalls: July 2023

The FDA posted 220 medical device recall records in July 2023, from 75 recall events by 62 companies. 35 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. MEDLINE INDUSTRIES, LP - Northfield · 4 events, 61 records
  2. Datascope Corp. · 3 events, 13 records, 4 Class I
  3. Baxter Healthcare Corporation · 3 events, 4 records, 2 Class I
  4. Olympus Corporation of the Americas · 2 events, 15 records, 7 Class I
  5. Abiomed, Inc. · 2 events, 7 records, 6 Class I
  6. Qiagen GmbH · 2 events, 3 records
  7. Beckman Coulter, Inc. · 2 events, 2 records
  8. NeuMoDx Molecular Inc · 2 events, 2 records

FDA root cause

  1. Device Design · 76
  2. Under Investigation by firm · 55
  3. Process control · 33
  4. Nonconforming Material/Component · 18
  5. Component design/selection · 10
  6. Software design · 7
  7. Process design · 5
  8. Other · 3

Class I recalls (35)

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

Class II recalls (183)

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

Class III recalls (2)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.