Baxter Recalls FLOSEAL Special Applicator Tips Due to Plastic Formulation Error
Baxter Healthcare is recalling FLOSEAL Special Applicator Tips because an incorrect plastic formulation was used in the blue luer component.
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, but the source text does not report any injuries, illnesses, or specific functional failures, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling FLOSEAL Special Applicator Tips. The recall involves 46,908 pouches distributed nationwide to 48 states and the District of Columbia, as well as internationally to Australia, Korea, Taiwan, and Columbia. The affected products are identified by Product Code 1502186, Box Lot Numbers HA170718, HA170818, and HA170917, and Pouch Lot Numbers GR338160 and GR338384.
The recall was initiated because an incorrect plastic formulation was used in the manufacture of the blue luer component of the FLOSEAL malleable tips. The source text does not specify the exact nature of the hazard or any reported injuries or illnesses associated with this defect.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to Baxter Healthcare Corporation or the distributor in accordance with the recall instructions.
The recalled product
- Product
- FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 46,908
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 (5)
- Product Code: 1502186
- Box Lot Numbers: HA170718
- HA170818
- and HA170917
- Pouch Lot Numbers: GR338160 and GR338384
Distribution
Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · material defect
See all →- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
Similar recalls
- ModerateBaxter FloSeal Hemostatic Matrix Recalled for Marketing Brochure Inaccuracies
FDA (Devices) · 2024-01-17
- ModerateBaxter Recalls Mislabeled 5 mL Oral Dispensers Due to Packaging Errors
FDA (Devices) · 2018-03-07
- LowBaxa Vial Adapter Recall for Incorrect Expiry Date
FDA (Devices) · 2013-09-18
- ModerateBaxter Flo-Rester Vessel Occluder Recall Due to Inaccurate Marketing Brochure
FDA (Devices) · 2024-01-17
- SevereBaxter Recalls Sodium Chloride Injection Bags Due to Plastic Fragments
FDA (Drugs) · 2015-04-15
- ModerateBaxter Recalls Potassium Chloride Injection Bags Due to Labeling Error
FDA (Drugs) · 2014-12-03