Sterile Kelly forceps recalled over weak seals that may breach sterility
Medline is recalling 53 sterile Kelly forceps because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.
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: Scored 3 under the risk-of-harm criterion: the firm states a seal failure may breach sterility and increase infection risk, and no injuries are reported.
Plain-English summary
The FORCEP, STD STR, STERILE KELLY, 5.5 IN, Medline item number DYNJ04048, is being recalled by Medline Industries, LP.
The items may have weak packaging seals that may result in a breach of sterility if the seal fails, and the firm states this may lead to an increased risk of infection if the product is used.
The record lists 53 units carrying UDI-DI 10193489195248 for each and 20193489195245 for the case, from lot 2023112290. Distribution was nationwide in the United States, in California, Colorado, Illinois, Kansas and Michigan. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow Medline's instructions.
The recalled product
- Product
- FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
- Manufacturer
- Medline Industries, LP
- Affected units
- 53
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 (4)
- DYNJ04048
- UDI-DI: 10193489195248(each)
- 20193489195245(case)
- Lot Number: 2023112290
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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