The Recall Desk
ModerateFDA (Devices)·Z-0275-2022·Announced 2021-12-01

da Vinci Surgical Drapes Recalled for Incorrect Expiration Date on Packaging

Intuitive Surgical recalls 1,740 da Vinci Instrument Arm Drapes due to incorrect expiration dates on package labeling. The error may prevent accurate verification of sterility assurance dates.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II medical device recall for incorrect expiration date labeling on sterile surgical drapes. No illnesses, injuries, or adverse events are reported in the source text. The labeling error is a documentation issue, not an inherent product defect, consistent with Score 2 criteria for labeling errors.

Plain-English summary

Intuitive Surgical, Inc. is recalling 1,740 da Vinci Instrument Arm Drapes (part number 470015-07, lot DM4210309, UDI 00886874112199). These sterile single-use surgical drapes are used on the instrument arms of the da Vinci Xi (IS4000) and X (IS4200) surgical systems to serve as a sterile barrier during surgical procedures.

The drapes are being recalled because the package labeling contains incorrect expiration dates on both the shipper box and inner carton labels. This labeling error prevents accurate verification of the sterility assurance period.

The affected drapes were distributed worldwide, including throughout the United States (AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT) and to South Korea.

Healthcare facilities that may have received the affected drapes should verify lot numbers and confirm actual sterility expiration dates with the manufacturer. Facilities are advised to contact Intuitive Surgical for replacement drapes and additional information regarding this recall.

The recalled product

Product
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instru
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Drapes
Hazard
  • mislabeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Part number: 470015-07
  • Lot number: DM4210309
  • REF: 470015
  • UDI # 00886874112199.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category