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.
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: 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
Related recalls
Same manufacturer · Remington Medical, Inc.
See all →- ModerateRemington Medical drainage bags recalled due to packaging label date error
FDA (Devices) · 2023-12-13
- ModerateRemington Medical Recalls FAS-LOC Extension Cables Due to Labeling Error
FDA (Devices) · 2014-04-16
- SevereRemington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns
FDA (Devices) · 2012-10-17
Same hazard · dimensional defect
See all →- HighMedline ENFit G-tube connectors may leak from dimensional specification failure
FDA (Devices) · 2026-04-08
- HighMedline ENFit G-tube connector kits may leak from dimensional defect
FDA (Devices) · 2026-04-08
- HighAesculap MINOP trocar shafts may be longer than specified
FDA (Devices) · 2026-03-11
- ModerateMedline Soft Liner Dimensional Variation May Affect Outer Canister Fit
FDA (Devices) · 2024-08-28
- ModerateMedical Device Liner Recalled for Dimensional Variation Affecting Fit
FDA (Devices) · 2024-08-28
Similar recalls
- SevereRemington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns
FDA (Devices) · 2012-10-17
- ModerateRepro-Med Systems Recalls Mislabeled Subcutaneous Safety Needle Sets
FDA (Devices) · 2019-10-16
- ModerateAmendia Dual Stylet Needle Recall Due to Unacceptable Packaging Seals
FDA (Devices) · 2016-12-28
- HighMedline Extended PTFE Needle Recall for Sterility Concerns
FDA (Devices) · 2012-09-05
- ModerateDePuy Mitek Recalls FMS neXtra 3.5mm Cutter Shaver Blades Due to Labeling Error
FDA (Devices) · 2016-01-27
- HighAvid Medical Recalls TruCustom Upper Extremity Kits Due to Foreign Material
FDA (Devices) · 2018-03-07