Hemopore nasal wound dressing packaging seal defect may compromise sterility
Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for a medical device with a potential sterility seal breach. No illnesses or injuries have been reported, and the hazard is theoretical. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Stryker Corporation has issued a recall for 182,344 units of Hemopore 8cm nasal/sinus temporary wound dressing (Catalog Numbers 5400-020-208 and 5400-020-208ITL). The products affected were distributed nationwide in the United States.
The blister seals on these products may develop a bubble on the seal area of the packaging. The packaging seal acts as a sterile barrier, and a bubble indicates that the sterility seal may have been breached, potentially allowing contamination of the device.
Healthcare providers and patients using affected lot numbers should discontinue use. Contact Stryker Corporation with questions about returns or replacements. If you have concerns about exposure to a potentially non-sterile device, consult your healthcare provider.
The recalled product
- Product
- Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Wound Dressing
- Affected units
- 182,344
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 (3)
- 5400-020-208 UDI-DI: 07613327117233
- 5400-020-208ITL UDI-DI: 07613327602623
- Lot Numbers: 2024052333
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Stryker Corporation
See all →- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- SevereStryker Recalls Break-Away Femoral Nozzles Due to Sterility Concerns
FDA (Devices) · 2018-04-04
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect
FDA (Devices) · 2019-10-30
- HighStryker End Cap Recall Due to Potential Sterility Compromise
FDA (Devices) · 2020-06-24
- HighSmith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Defects
FDA (Devices) · 2020-10-28
- ModerateSmith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects
FDA (Devices) · 2020-10-28