Remington Medical Automatic Cutting Needle Stylet Longer Than Specified
Remington Medical is recalling 290 Automatic Cutting Needles with lot number 2224920 because the stylet is longer than specified on the label. Affected units were distributed in NC, WV, CA, PA, AL, and TX.
What this means for you
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: This is an FDA Class II recall of a medical device with a confirmed dimensional defect (stylet longer than specified), which could result in patient harm. However, no injuries or illnesses have been reported, placing it in the High category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Remington Medical, Inc. is recalling Remington MEDICAL Automatic Cutting Needles (18ga, 1.3mm x 20cm, Reference NAC-1820M) due to a dimensional defect. Specifically, the stylet (needle component) is longer than specified on the product label.
The recall affects 290 devices with Lot Number 2224920 and an expiration date of September 2025. The affected devices were distributed to healthcare facilities and providers in North Carolina, West Virginia, California, Pennsylvania, Alabama, and Texas.
Healthcare providers and facilities should immediately stop using these devices and contact Remington Medical, Inc. for instructions on how to return or destroy the affected needles.
The recalled product
- Product
- Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
- Manufacturer
- Remington Medical, Inc.
- Category
- Medical Device — Surgical Needle
- Hazard
- Affected units
- 290
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 (3)
- UDI/DI 00813079020936
- Lot Number 2224920
- exp. 2025-09/06
Distribution
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