Bound Tree Medical Recalls Curaplex Epi Kits Due to Incorrect Instructions
Bound Tree Medical is recalling 339 Curaplex Epi Kits because the instructions recommend an unapproved epinephrine dosage for young children.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the recall involves a medication dosage error that could result in the administration of an inappropriate dosage of epinephrine to children, meeting the criteria for a Severe rating.
Plain-English summary
Bound Tree Medical, LLC is recalling 339 units of the Curaplex Epi Kit, model #8600-01120. The kits contain Safety-LOK Syringes, epinephrine vials, and other medical supplies. The product was distributed nationwide in the United States.
The recall was initiated because the Instructions for Use (IFU) included in the kits recommend a midpoint dosage of epinephrine for children between 0 and 66 pounds that has not been approved by the FDA. The instructions suggest a dosage of 0.15 mL for this weight range. Additionally, the Epi-Safe syringe lacks the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Reliance on the current instructions or use of the syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, particularly those under 33 pounds. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. Rx Only. Distributed by Sarnova HC…
- Manufacturer
- Bound Tree Medical, LLC
- Category
- Drug — Epinephrine Auto-Injector
- Hazard
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)
- all lot numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Bound Tree Medical, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Bound Tree Medical, LLC
See all →- HighBound Tree Medical Recalls Curaplex Epi Safe Training Kits Due to Labeling Errors
FDA (Drugs) · 2019-01-30
- SevereBound Tree Medical Recalls Epi Safe Kits Due to Incorrect Instructions
FDA (Drugs) · 2019-01-30
- SevereRecall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions
FDA (Drugs) · 2019-01-30
- LowBound Tree Medical Recalls Curaplex Epi Safe Kits Due to Labeling Errors
FDA (Drugs) · 2019-01-23
- ModerateRecall of Curaplex Epi Safe Kits Due to Expired Epinephrine Vials
FDA (Drugs) · 2019-01-23
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- 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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowBound Tree Medical Recalls Curaplex Epi Safe Kits Due to Labeling Errors
FDA (Drugs) · 2019-01-23
- ModerateRecall of Curaplex Epi Safe Kits Due to Expired Epinephrine Vials
FDA (Drugs) · 2019-01-23
- HighEpinephrine Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-07-27
- LowEdge Pharma Recalls Epinephrine/Lidocaine Ophthalmic Solution Due to Labeling Errors
FDA (Drugs) · 2021-03-24
- SeverePharmakon Recalls Epinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27