MicroAire K-Wires Recalled for Incorrect Product Labeling
MicroAire Surgical Instruments is recalling 362 K-Wires due to mislabeling that incorrectly identified them as dual trocar instead of single trocar.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding product description, which fits the criteria for moderate severity.
Plain-English summary
MicroAire Surgical Instruments, LLC is recalling 362 units of MicroAire K-Wires. The recall is due to mislabeling on the product labels for three specific lots. The labels incorrectly described the product as "dual trocar" when the correct description is "single trocar."
The affected products are distributed in the United States. The specific part numbers and lot numbers involved are 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856). The total quantity distributed to the field is 362 units.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should check their inventory for these specific part and lot numbers and stop using the affected products if found.
The recalled product
- Product
- MicroAire K-Wires
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Hazard
- Affected units
- 362
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 (11)
- Part Number
- Lot Number
- Quantity Distributed to Field 1600-9355NS
- 61005
- 56
- 1600-9625NS
- 60297
- 209
- 1604-162NS
- 62856
- 97.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · MicroAire Surgical Instruments, LLC
See all →- HighSmartRelease Onyx Blade Assembly Surgical System Recalled
FDA (Devices) · 2025-06-18
- HighMicroAire SmartRelease Endoscopic Carpal Tunnel Handpiece Recall
FDA (Devices) · 2019-08-14
- ModerateMicroAire SmartRelease Endoscopic System Recalled for Incorrect Sterilization Instructions
FDA (Devices) · 2018-06-13
- HighMicroAire Recalls Sterile Twist Drills Due to Incorrect Size Inclusion
FDA (Devices) · 2018-02-07
- ModerateMicroAire Recalls Endotine Transbleph 3.5 Due to Minor Mislabeling
FDA (Devices) · 2016-08-03
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighMicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals
FDA (Devices) · 2013-09-11
- ModerateStryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
FDA (Devices) · 2019-11-06
- ModerateMicroAire Recalls Endotine Transbleph 3.5 Due to Minor Mislabeling
FDA (Devices) · 2016-08-03
- ModerateCook Inc. Recalls Coons Interventional Wire Guide Due to Labeling Error
FDA (Devices) · 2018-03-21
- ModerateCook Inc. Recalls Double Flexible Tipped Wire Guides Due to Labeling Error
FDA (Devices) · 2018-03-21
- ModerateMedicrea Pass LP Trocar K-wire Recalled for Fit Issues
FDA (Devices) · 2020-01-29