Teleflex Pilling Knife Handles Recalled for Blade Fit Issues
Teleflex Medical is recalling Pilling Knife Handles because the slot depth is out of specification, which may prevent blades from fitting properly.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a functional defect (blade fit) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teleflex Medical is recalling specific Pilling Knife Handles (REF 352950, 352953, 352951, 352957, and 352952) due to a manufacturing defect. The slot depth on these reusable surgical knife handles is out of specification, which may result in blades not fitting onto the handles properly.
The recall affects 6,197 units that were distributed worldwide, including the United States, Canada, France, Taiwan, Argentina, Australia, South Korea, Belgium, Singapore, India, Indonesia, the Philippines, and Thailand. Specific lot numbers are listed for each reference number in the agency's documentation.
Healthcare facilities and users should stop using the affected knife handles and contact Teleflex Medical for instructions on return or replacement. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 6,197
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 (13)
- a) REF 352950: Lot numbers: D6
- J6
- E6
- F6
- G6
- H6
- I6 b) REF 352953: Lot numbers: I6
- B6
- E6 c) REF 352951: Lot numbers: I6
- J6 d) REF 352957: Lot numbers: A6
- B7
- K6
- L6 e) REF 352952: Lot numbers: H6
Distribution
Distributed nationwide across the United States.
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