Severity
Low
FDA Devices recall · Reported October 5, 2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between …
Mckesson Medical-Surgical Inc. Corporate Office recalled SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO… - a low-severity action.
SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO… was recalled by Mckesson Medical-Surgical Inc. Corporate Office in October 5, 2022. Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatur…. Check the official notice for the remedy. Verify recall #Z-1791-2022 with the FDA Devices before acting.
The recall
Mckesson Medical-Surgical Inc. Corporate Office issued this low-severity FDA Devices recall-Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatur….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1791-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1791-2022) was formally reported on October 5, 2022, with the manufacturer initiating the action on May 25, 2022. It is classified under Low severity (Class III), with a current status of Ongoing. Mckesson Medical-Surgical Inc. Corporate Office is listed as the recalling firm, operating out of Richmond, VA. Federal records list the affected scope as 1 case.
The documented reason for this recall is: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Distribution data in the federal record shows the product reached: US Nationwide distribution.. 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.
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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
1 case
Related Recalls
6
3 from same agency
SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-1791-2022 |
| Date reported | October 5, 2022 |
| Date initiated | May 25, 2022 |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Firm location | Richmond, VA |
| Affected scope | 1 case |
| Distribution | US Nationwide distribution. |
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.
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.
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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 October 5, 2022. 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.