Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 26, 2020
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical…
Cardinal Health 200, LLC recalled Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Number… — a moderate-severity action.
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Number… was recalled by Cardinal Health 200, LLC in February 26, 2020. Reason: The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain pr…. Check the official notice for the remedy. Verify recall #Z-1301-2020 with the FDA Devices before acting.
The recall
Cardinal Health 200, LLC issued this moderate-severity FDA Devices recall — The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain pr….
- Moderate
- severity level
- 318K units
- affected scope
- Class II
- classification
- February 26, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1301-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1301-2020) was formally reported on February 26, 2020, with the manufacturer initiating the action on January 31, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Waukegan, IL. Federal records list the affected scope as 318,000 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately ster… Distribution data in the federal record shows the product reached: US Nationwide. Chile, Israel, UAE.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
318,000 units
Related Recalls
6
6 from same agency
Product description
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
Reason for recall
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1301-2020 |
| Date reported | February 26, 2020 |
| Date initiated | January 31, 2020 |
| Recalling firm | Cardinal Health 200, LLC |
| Firm location | Waukegan, IL |
| Affected scope | 318,000 units |
| Distribution | US Nationwide. Chile, Israel, UAE. |
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-1301-2020) 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? ▼
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Recalled by Cardinal Health 200, LLC. Units affected: 318,000 units.
Why was this product recalled? ▼
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1301-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide. Chile, Israel, UAE..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1301-2020) 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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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported February 26, 2020.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.