PODD · 10-Q · 2026Q2 · Full report

Product Safety Corrections

INSULET CORP · 2026-08-05 · Importance 59 · Surprise 60 · In source text

During the six months ended June 30, 2026, Insulet issued two voluntary medical device corrections, in March and May, for separate manufacturing issues that could cause a tear in the cannula of certain Omnipod products. The company recorded net charges of $29.3 million in the second quarter and $41.0 million for the six-month period. Insulet estimates total correction-related costs of $60 million to $70 million, with most incurred in 2026 and the remainder in 2027 for manual quality inspections until automated inspection systems are implemented.

Key facts

• The Company estimates the MDCs and related costs will be in the range of $60 million to $70 million, most of which it expects to incur in 2026, with the remainder expected to be incurred in 2027. source
• During the six months ended June 30, 2026, the Company issued two voluntary medical device corrections (MDCs), one in March and the other in May related to separate manufacturing issues that caused a tear in the cannula of certain Omnipod products. source
• Voluntary MDCs and related costs were $25.0 million for the three months ended June 30, 2026 and $36.7 million for the six months ended June 30, 2026. source
• The Company recorded a net charge associated with the MDCs of $29.3 million and $41.0 million for the three and six months ended June 30, 2026, respectively. source
• Warranty expense - voluntary medical device corrections during the three and six months ended June 30, 2026: $25.3 million and $37.0 million, respectively. source
• Product warranty liability at end of period (June 30, 2026): $33.4 million, up from $16.8 million at beginning of period for three months (and $16.8 beginning and $33.4 end for six months). source
• These increases in gross margin were partially offset by higher warranty costs resulting from the voluntary medical device correction issued in May 2026. source

Impact estimates