Surgical gloves recalled for incomplete sterile pouch sealing
Ansell Healthcare Products LLC has recalled certain NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Improper sealing could allow contamination before use.
What this means for you
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 an FDA Class II medical device recall for a surgical product with potential for contamination if sterile pouches are compromised. No illnesses or injuries have been reported, placing this in the High severity category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ansell Healthcare Products LLC is recalling NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves due to incomplete sealing of sterile pouches. The affected gloves have reference numbers V20685255 through V20685290 and are from lot 2203434604, totaling 378 units.
Some sterile pouches were not completely sealed during manufacturing. Incomplete sealing could potentially allow bacterial contamination of the surgical gloves before they are used.
The recalled gloves were distributed nationwide in Indiana, Ohio, New York, Virginia, Illinois, Tennessee, Georgia, South Carolina, Wisconsin, Florida, and Canada.
The recalled product
- Product
- NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
- Manufacturer
- Ansell Healthcare Products LLC
- Category
- Medical Device — Surgical gloves
- Affected units
- 378
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 (9)
- Lot: 2203434604
- REF/UDI-DI: V20685255/10014566400553
- V20685260/10014566400607
- V20685265/10014566400652
- V20685270/10014566400706
- V20685275/10014566400751
- V20685280/10014566400805
- V20685285/10014566400850
- V20685290/10014566400904.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ansell Healthcare Products LLC 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 2 products in this recall →Related recalls
Same manufacturer · Ansell Healthcare Products LLC
See all →- HighGAMMEX NON-LATEX PI GREEN Surgical Gloves with Unsealed Sterile Pouches
FDA (Devices) · 2023-10-18
- ModerateSurgical Gloves Recalled Due to Missed FDA Border Inspection
FDA (Devices) · 2022-04-06
- HighAnsell Microflex Diamond Grip Examination Gloves Recalled for Barrier Integrity Verification
FDA (Devices) · 2020-10-14
- HighAnsell Recalls Gammex Surgical Gloves Due to Latex Contamination
FDA (Devices) · 2016-12-28
- ModerateAnsell Recalls LifeStyles ZERO 10 Latex Condoms Due to Breakage Complaints
FDA (Devices) · 2013-02-27
Same hazard · contamination risk
See all →- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
- SevereMedical Convenience Kits Recalled Over Lidocaine Injection Supplier Quality Issues
FDA (Devices) · 2026-08-05