FDA Recalls Surgical Instrument Handle That May Break During Use
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical instrument with documented potential for material failure during intraoperative use. No incidents or injuries are reported in the source, making this a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
The FDA is recalling certain lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight (Item Number 130-394/01), manufactured by Waldemar Link GmbH & Co. KG. A total of 32 devices were distributed.
Some lots of this surgical instrument may experience an immediate material failure when first used during surgery. The instrument can break in the middle during intraoperative use, which could compromise patient safety.
The affected lots were distributed nationwide in the states of Florida, Kansas, Michigan, New Jersey, and Virginia. The recalled lot codes are: C204156, C219063, C219064, C233033, C233034, and C332135.
The recalled product
- Product
- LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
- Manufacturer
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Hazard
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI: 04026575215539
- Lot Codes: C204156
- C219063
- C219064
- C233033
- C233034
- C332135
Distribution
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