Skip to content

Medical device recalls: June 2023

The FDA posted 376 medical device recall records in June 2023, from 71 recall events by 69 companies. 260 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. Karl Storz Endoscopy · 2 events, 2 records
  2. Medtronic Navigation, Inc. · 2 events, 2 records, 2 Class I
  3. Teleflex LLC · 1 event, 123 records, 123 Class I
  4. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 1 event, 120 records, 120 Class I
  5. Merit Medical Systems, Inc. · 1 event, 13 records
  6. Megadyne Medical Products, Inc. · 1 event, 8 records, 8 Class I
  7. Full Vision Inc · 1 event, 7 records
  8. Avanos Medical, Inc. · 1 event, 5 records

FDA root cause

  1. Under Investigation by firm · 283
  2. Process control · 22
  3. Device Design · 13
  4. Nonconforming Material/Component · 12
  5. Other · 9
  6. Use error · 5
  7. Software design · 5
  8. Process design · 4

Class I recalls (260)

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

Class II recalls (109)

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

Class III recalls (7)

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.