Symmetry Surgical GmbH
4 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (4)
Devices registered here (1)
- Forceps, Rongeur, SurgicalProduct code EMH (opens in a new tab) · Class I · Dental · 21 CFR 872.4565
Recalls & enforcement
- Class IICompleted2024-06-03The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
- Class IITerminated2021-07-23Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the p…
- Class IITerminated2014-03-20The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
- Class IITerminated2013-07-18Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have b…
Related
- All facilities operated by Aspen Surgical Products
- Industrias Apson S.A de C.V (MX)
- ASPEN SURGICAL PRODUCTS, INC. (MI)
- Aspen Surgical Products, Inc. (AZ)
- Aspen Surgical Puerto Rico Corp. (PR)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Symmetry Surgical GmbH (FEI 3001644167) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001644167-symmetry-surgical-gmbh/
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