Centurion Nasal Speculums Recalled for Incomplete Sterile Package Seals
Centurion Medical Products is recalling 1,820 sterile nasal speculums due to incomplete package seals that may compromise sterility.
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: The recall involves a sterile medical device where compromised sterility poses a risk of harm (infection), but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling 1,820 units of Centurion Nasal Speculums (NSP500ST). The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the device.
The affected product is identified by Lot Number 2019010990. Distribution was nationwide and to Ghana.
Consumers and healthcare providers should stop using the affected product and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 1,820
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 (1)
- Lot Number: 2019010990
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Centurion Medical Products Corporation 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.
See all 54 products in this recall →Related recalls
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