Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 23, 2024
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
Specific lots of product have been manufactured with nonconforming raw materials.
Wilson-Cook Medical Inc. recalled Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-… - a moderate-severity action.
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-… was recalled by Wilson-Cook Medical Inc. in October 23, 2024. Reason: Specific lots of product have been manufactured with nonconforming raw materials.. Check the official notice for the remedy. Verify recall #Z-0036-2025 with the FDA Devices before acting.
The recall
Wilson-Cook Medical Inc. issued this moderate-severity FDA Devices recall-Specific lots of product have been manufactured with nonconforming raw materials..
- Moderate
- severity level
- Class II
- classification
- October 23, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0036-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0036-2025) was formally reported on October 23, 2024, with the manufacturer initiating the action on August 29, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Wilson-Cook Medical Inc. is listed as the recalling firm, operating out of Winston Salem, NC. Federal records list the affected scope as UPDATE-4,605 devices.
The documented reason for this recall is: Specific lots of product have been manufactured with nonconforming raw materials. Distribution data in the federal record shows the product reached: Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austri…. 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
UPDATE-4,605 devices
Related Recalls
6
3 from same agency
Product description
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
Reason for recall
Specific lots of product have been manufactured with nonconforming raw materials.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0036-2025 |
| Date reported | October 23, 2024 |
| Date initiated | August 29, 2024 |
| Recalling firm | Wilson-Cook Medical Inc. |
| Firm location | Winston Salem, NC |
| Affected scope | UPDATE-4,605 devices |
| Distribution | Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austria, Belgium, Canada, … |
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-0036-2025) 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? ▼
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.. Recalled by Wilson-Cook Medical Inc.. Units affected: UPDATE-4,605 devices.
Why was this product recalled? ▼
Specific lots of product have been manufactured with nonconforming raw materials.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2024. Severity: Moderate. Recall number: Z-0036-2025.
Where was the recalled product distributed? ▼
Distribution: Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Latvia, Luxembourg, Mexico, Myanmar, Netherlands, Norway, New Zealand, Poland, Portugal, Romania, Singapore, Spain, Sweden, Switzerland, Thailand, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0036-2025) 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 October 23, 2024. 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.