Terumo Medical Recalls 23G Needles Due to Potential Sterility Compromise
Terumo Medical Corporation is recalling 30,000 units of 23G x 1-inch needles (Lot 180811C) because a potential loss of package integrity may compromise the product's 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 risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential compromise of sterility without confirmed adverse events.
Plain-English summary
Terumo Medical Corporation is recalling 30,000 units of Terumo Needle, 23G x 1" (Product Code NN2325R, Lot Number 180811C). The recall was initiated because there is a potential for a loss of package integrity that may compromise the sterility of the product.
The affected products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX. The source text does not specify the exact number of units distributed to each state or the specific facilities receiving the product.
Consumers and healthcare facilities should stop using the affected needles and contact Terumo Medical Corporation for further instructions or a replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Terumo Needle, 23G x 1", Product Code NN2325R
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 30,000
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 Numbers 180811C
Distribution
Part of a larger recall action
This product is one of 9 recalled by Terumo Medical 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 9 products in this recall →Related recalls
Same manufacturer · Terumo Medical Corporation
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- HighTerumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
FDA (Devices) · 2019-07-31
- ModerateTerumo 30G Needle Recall Due to Potential Sterility Compromise
FDA (Devices) · 2019-07-31
- ModerateTerumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
FDA (Devices) · 2019-07-31
- HighTerumo 18G Needles Recalled for Potential Loss of Package Integrity
FDA (Devices) · 2019-07-31
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighCarefusion Recalls Jamshidi Needles Due to Compromised Sterile Packaging
FDA (Devices) · 2018-04-25
- HighSoft Tissue Biopsy Needles Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-09-29
- HighCarefusion 2200 Recalls Jamshidi Bone Marrow Needles Due to Packaging Integrity
FDA (Devices) · 2018-04-25
- HighCarefusion Illinois Needle Aspiration Recall Due to Compromised Sterile Packaging
FDA (Devices) · 2018-04-25
- HighMedline Recalls Sterile Syringes Due to Packaging Seal Voids
FDA (Devices) · 2020-04-01
- HighBone Marrow Biopsy Needles Recalled for Sterility Assurance Concerns
FDA (Devices) · 2021-09-29