Ace Surgical Supply Recalls Mispackaged Double Blade Shoe Unigraft Knives
Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knives because a single blade shoe was mistakenly packaged instead of the intended double blade.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a packaging-only problem involving a mispackaged component with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM (SKU 6500009, Lot # M050225). These medical devices are used to achieve epithelial grafts in the oral cavity.
The recall was initiated because the product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of the intended double blade.
The affected units were distributed in the United States to Michigan, California, and Oklahoma, as well as internationally to China and Canada. Consumers and healthcare providers should stop using the product and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
- Manufacturer
- Ace Surgical Supply Co., Inc.
- Hazard
- Affected units
- 6
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 # M050225
Distribution
Related recalls
Same manufacturer · Ace Surgical Supply Co., Inc.
See all →- HighNuOss Collagen Blocks Recalled Due to Product Substitution Error
FDA (Devices) · 2022-03-30
- ModerateAce Surgical Recalls Mislabeled Succinylcholine Vials Due to Expiration Date Error
FDA (Drugs) · 2017-11-15
- ModerateAce Surgical Supply Recalls Incorrectly Packaged Dental Abutments
FDA (Devices) · 2017-04-26
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 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
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- HighAlcon ClearCut and A-OK Ophthalmic Knives Recalled for Reduced Sharpness
FDA (Devices) · 2024-08-28
- HighClearCut Sideport Ophthalmic Knives Recalled Due to Sharpness Issues
FDA (Devices) · 2024-08-28
- HighAmerican Surgical Company Recalls Neurosurgical Sponges Due to Packaging Defect
FDA (Devices) · 2016-06-01
- HighOphthalmic Knives Recalled Due to Complaints About Reduced Sharpness
FDA (Devices) · 2024-08-28
- HighOphthalmic surgical knives recalled due to sharpness complaints
FDA (Devices) · 2024-06-05
- HighOphthalmic Surgical Knives Recalled for Potential Sharpness Issues
FDA (Devices) · 2024-08-28