Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 1, 2021
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 instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for s
Incorrect expiration date on its package labeling (shipper box and inner carton label).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Intuitive Surgical, Inc. recalled The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main com… - a moderate-severity action.
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main com… was recalled by Intuitive Surgical, Inc. in December 1, 2021. Reason: Incorrect expiration date on its package labeling (shipper box and inner carton label).. Check the official notice for the remedy. Verify recall #Z-0275-2022 with the FDA Devices before acting.
The recall
Intuitive Surgical, Inc. issued this moderate-severity FDA Devices recall-Incorrect expiration date on its package labeling (shipper box and inner carton label)..
- Moderate
- severity level
- Class II
- classification
- December 1, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0275-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0275-2022) was formally reported on December 1, 2021, with the manufacturer initiating the action on September 21, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Intuitive Surgical, Inc. is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records list the affected scope as 1,740 drapes (87 bobes).
The documented reason for this recall is: Incorrect expiration date on its package labeling (shipper box and inner carton label). Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,740 drapes (87 bobes)
Related Recalls
6
3 from same agency
Product description
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 instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.
Reason for recall
Incorrect expiration date on its package labeling (shipper box and inner carton label).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0275-2022 |
| Date reported | December 1, 2021 |
| Date initiated | September 21, 2021 |
| Recalling firm | Intuitive Surgical, Inc. |
| Firm location | Sunnyvale, CA |
| Affected scope | 1,740 drapes (87 bobes) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0275-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.. Recalled by Intuitive Surgical, Inc.. Units affected: 1,740 drapes (87 bobes).
Why was this product recalled? ▼
Incorrect expiration date on its package labeling (shipper box and inner carton label).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0275-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0275-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 1, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.