TZ Medical Neptune Plus Hemostasis Pad Recall for Labeling Mismatch
TZ Medical Inc. is recalling Neptune Plus hemostasis pads because the instructions for use do not match the original FDA submission.
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 due to a labeling error (IFU mismatch) which is a minor documentation issue unlikely to cause serious harm, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
TZ Medical Inc. is recalling 32,170 units of Neptune Plus Hemostasis Pads with Antimicrobial Barrier, Part number 8870-03. The recall is due to a discrepancy where the instructions for use (IFU) of the pads do not match the documentation submitted in the original 510k application. Specifically, the phrase "for haemostasis following needle/sheath removal" needs to be removed from the IFU.
The affected products were distributed nationwide in the United States. The recall involves specific lot numbers: AGR554, AGR554\20, AGR554\24, AGR554/24, AGR570\28, AGR570/43, AGR744124, and AGR744137.
This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences. Healthcare providers and consumers should stop using the affected lots and contact TZ Medical Inc. for further instructions or replacement.
The recalled product
- Product
- Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
- Manufacturer
- TZ Medical Inc.
- Category
- Medical Device — Hemostasis Pads
- Hazard
- Affected units
- 32,170
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 (8)
- Lot Numbers: AGR554
- AGR554\20
- AGR554\24
- AGR554/24
- AGR570\28
- AGR570/43
- AGR744124
- AGR744137.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · TZ Medical Inc.
See all →- ModerateTZ Medical Recalls Mis-Labeled Neptune Plus Hemostatic Pads
FDA (Devices) · 2016-11-02
- ModerateTZ Medical Recalls SilverStat Hemostasis Pads Due to Labeling Discrepancy
FDA (Devices) · 2015-11-25
- HighTZ Medical Recalls Defibrillation Electrodes Due to Defective White Wire
FDA (Devices) · 2013-06-05
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- 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
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
Similar recalls
- ModerateTZ Medical Recalls Mis-Labeled Neptune Plus Hemostatic Pads
FDA (Devices) · 2016-11-02
- ModerateTZ Medical Recalls SilverStat Hemostasis Pads Due to Labeling Discrepancy
FDA (Devices) · 2015-11-25
- ModeratePharmaceutical Innovations Recalls Ultra/Phonic Focus BP Conforming Gel Pads
FDA (Devices) · 2020-08-26
- ModerateSmith & Nephew Recalls Renasys EZ PLUS Canisters for Labeling Changes
FDA (Devices) · 2014-03-05
- ModerateZimmer Biomet Recalls Mismatched Hip Implant Packages
FDA (Devices) · 2018-04-04
- HighZimmer Biomet Recalls Mismatched Hip Implant Packages Due to Sizing Error
FDA (Devices) · 2018-04-04