Aesculap Prestige Retraction Grasper Recall: Risk of Handle Separation
Aesculap recalls Prestige Retraction Graspers with potential handle separation. Affected models include 8361-10 (UDI-DI: 04046955083381) sold in specific lots. Stop using immediately to avoid injury.
Stop using this now
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Contact the company
What happened, in plain English
Aesculap is recalling a specific type of surgical grasper that may separate at the weld between the handle and shaft. This separation could cause injury during surgery if the device becomes detached. Read more at govinfonow.com/recall/65581-aesculap-prestige-retraction-grasper-recall-risk-of-handle-separation.
Source Summary by GovInfoNow · govinfonow.com/recall/65581-aesculap-prestige-retraction-grasper-recall-risk-of-handle-separation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1482-2022
Cite this page
“Aesculap Prestige Retraction Grasper Recall: Risk of Handle Separation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65581-aesculap-prestige-retraction-grasper-recall-risk-of-handle-separation. Based on FDA recall #Z-1482-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1482-2022%22&limit=1).
Why it’s dangerous
The grasper's handle and shaft can become disconnected at the weld point during use. This separation could lead to the device becoming loose or detached, potentially causing injury to the surgical site or patient.
Who’s affected
Surgical professionals using the recalled grasper models are affected. Patients undergoing surgery with this device are at risk of injury if the handle separates during procedure.
How to tell if you have this one
Check for the product code 8361-10 on the device. Look for UDI-DI: 04046955083381 and lots M45171, M46651, M47463, M48124, or M49436.
- Brand
Aesculap- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Completed- Distribution
United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1481-2022 | PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10; UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796. | 3392 |
| Z-1482-2022 | PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10; UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436. | 399 |
What to do — step by step
Stop Using Immediately
Discontinue use of the affected grasper to prevent potential handle separation during surgery.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 46 states.
FDA distribution: “United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1482-2022 (April 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1482-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.