CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell recalled
Ansell Healthcare Products is recalling Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd, distributed in Florida, Illinois, Massachusetts, New Jersey, Pennsylvania. The recall was initiated on 24 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0893-2017
- FDA event ID
- 75737
- Recalling firm
- Ansell Healthcare Products, Iselin, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 24 Oct 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +59 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
Where it was distributed
US Distribution to the states of : PA, FL, NJ, IL and MA.
Questions about this recall
Why was it recalled?
Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
Which lots are affected?
Lot 1607018105
Where was it sold?
US Distribution to the states of : PA, FL, NJ, IL and MA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ansell Healthcare Products
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Gammex Non-latex PI Green Surgical gloves recalled | Ansell Healthcare Products | Sterility | Nationwide |
| Device | CLASS II | Novaplus Gammex Non-latex PI Green Surgical gloves recalled | Ansell Healthcare Products | Sterility | Nationwide |
| Device | CLASS II | Gammex Non-Latex PI Green Pi-kare Skin-friendly PI recalled | Ansell Healthcare Products | Processing Deviation | 6 states |
| Device | CLASS II | Microflex Diamond Grip Examination Gloves, MF recalled | Ansell Healthcare Products | Other | Nationwide |
| Device | CLASS II | LifeStyles ZERO 10 uber-thin lubricated latex condoms recalled | Ansell Healthcare Products | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |