Medline circumcision surgical kits recalled for sterility concerns
Medline Industries is recalling circumcision surgical trays due to potential lack of sterility in component solutions. The recall affects 1260 units distributed across the US, Puerto Rico, Canada, UAE, and Panama.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, the most serious medical device recall category. Non-sterile surgical instruments could pose significant infection risk during surgical procedures.
Plain-English summary
Medline Industries, LP is recalling Centurion surgical kits and trays (product REF DYNDA2271) because certain lots of component solutions may lack sterility. The affected components include Nurse Assist 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Non-sterile solutions used in surgical procedures could pose a patient safety risk.
A total of 1260 units have been distributed nationwide in the United States, Puerto Rico, Canada, United Arab Emirates, and Panama. Medical facilities and consumers with these kits should identify affected units by reference number DYNDA2271 and lot numbers 2022042590, 2022070190, 2022082290, 2022111490, 2023022190, 2023063090, and 2023090790.
The FDA has classified this as a Class I recall. Anyone with affected units should contact Medline Industries for replacement or return instructions.
The recalled product
- Product
- Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 1,260
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 (10)
- REF DYNDA2271
- UDI/DI 00653160318920 (case)
- 10653160318927 (unit)
- Lot Numbers: 2022042590
- 2022070190
- 2022082290
- 2022111490
- 2023022190
- 2023063090
- 2023090790
Distribution
Part of a larger recall action
This product is one of 49 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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