Sterile Magill Forceps Recalled Due to Weak Seals and Contamination Risk
Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.
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 device recall with sterility breach hazard creating risk of contamination and infection. No illnesses or injuries have been reported. Per rubric: risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Medline Industries, LP is recalling Sterile Magill Forceps (Model MAGF9, Item No. 66790) distributed nationwide due to a manufacturing defect affecting product sterility.
Weak seals in the packaging may result in a breach of sterility that may not be detectable to the user. This can lead to increased risk of contamination and infection during use.
The recall affects 21,440 units. Affected products are identified by UDI 00653160007671 (individual) and 50653160007676 (case), specifically Lot 2023012390 distributed in the United States.
Users in possession of affected units should discontinue use and consult Medline Industries for additional information regarding the recall.
The recalled product
- Product
- STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 21,440
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 (2)
- UDI: 00653160007671 (ea) 50653160007676 (case)
- Lot 2023012390
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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