CLASS II Device recall · Reported 10 Aug 2022 · FDA Enforcement Report
Prestige Retraction Grasper, W/port Dual Action, Rotating Diam recalled
Aesculap Implant Systems is recalling Prestige Retraction Grasper, W/port Dual Action, Rotating Diam, distributed nationwide in the US. The recall was initiated on 1 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1482-2022
- FDA event ID
- 90493
- Recalling firm
- Aesculap Implant Systems, Center Valley, PA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 1 Apr 2020
- FDA classified
- 29 Jul 2022
- Reported
- 10 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Apr 2020 | Recall initiated by company | |
| 29 Jul 2022 | Classified by FDA | +849 days |
| 10 Aug 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Product as listed by the FDA
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Which lots are affected?
UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 90493| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Prestige Atraumatic Grasper W/port Dual Action, Rotating Diam recalled | Aesculap Implant Systems | Other | Nationwide |
More recalls from Aesculap Implant Systems
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|---|---|---|---|---|---|
| Device | CLASS II | For intraventricular recalled by Aesculap Implant Systems | Aesculap Implant Systems | Device Malfunction | Nationwide |
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| Device | CLASS II | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled | Aesculap Implant Systems | Labeling Errors | Nationwide |
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