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Medical device recalls: March 2026

The FDA posted 217 medical device recall records in March 2026, from 77 recall events by 61 companies. 19 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. Olympus Corporation of the Americas · 5 events, 16 records
  2. Medline Industries, LP · 5 events, 7 records
  3. Philips Medical Systems Nederland B.V. · 2 events, 23 records
  4. Waldemar Link GmbH & Co. KG (Mfg Site) · 2 events, 15 records
  5. Intuitive Surgical, Inc. · 2 events, 6 records
  6. GE Medical Systems, LLC · 2 events, 4 records
  7. Datascope Corp. · 2 events, 3 records
  8. Abiomed, Inc. · 2 events, 2 records, 2 Class I

FDA root cause

  1. Under Investigation by firm · 48
  2. Device Design · 39
  3. Process control · 32
  4. Nonconforming Material/Component · 29
  5. No Marketing Application · 20
  6. Error in labeling · 12
  7. Software design · 10
  8. Process change control · 8

Class I recalls (19)

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

Class II recalls (176)

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

Class III recalls (22)

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.