Home › Aesculap AG › AESCULAP
AESCULAP
Aesculap AG · Model BA836SU · UDI-DI 04046963840884
GDX
Prescription
10
510(k) clearances
127
Adverse events
6
Recalls
164
Facilities
Description
Scalpel, polymer handle, Fig. 36, carbon steel, sterile, disposable, package of 10 pieces
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-06 | Southmedic, Inc. | Scalpels lot contains non-sterile products labeled as sterile. |
| 2015-08-18 | Zien Medical Technologies, Inc | Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause anal |
| 2013-02-07 | Myco Medical Supplies Inc | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.