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Medical device recalls: February 2026

The FDA posted 262 medical device recall records in February 2026, from 61 recall events by 46 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. Medline Industries, LP · 7 events, 74 records, 7 Class I
  2. Olympus Corporation of the Americas · 6 events, 69 records, 3 Class I
  3. Intuitive Surgical, Inc. · 3 events, 3 records
  4. Encore Medical, LP · 2 events, 5 records
  5. Wilson-Cook Medical Inc. · 2 events, 2 records
  6. Vortex Surgical Inc. · 1 event, 13 records
  7. Changchun Wancheng Bio-Electron Co., Ltd. · 1 event, 11 records
  8. Philips Medical Systems Nederland B.V. · 1 event, 8 records

FDA root cause

  1. Under Investigation by firm · 115
  2. Process control · 51
  3. Employee error · 15
  4. Device Design · 14
  5. No Marketing Application · 13
  6. Component design/selection · 12
  7. Packaging change control · 11
  8. Software design · 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 (237)

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

Class III recalls (6)

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.