CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report
Powdered Surgical Gloves, labeled as recalled
American Contract Systems is recalling Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves, distributed in Illinois, Missouri, Nebraska, Ohio. The recall was initiated on 28 Dec 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-0456-2019
- FDA event ID
- 80754
- Recalling firm
- American Contract Systems, Kansas City, MO
- Brand
- Ansell
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Dec 2016
- FDA classified
- 13 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 28 Dec 2016 | Recall initiated by company | |
| 13 Nov 2018 | Classified by FDA | +685 days |
| 21 Nov 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Powdered Surgical Gloves are an FDA banned substance.
Product as listed by the FDA
Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.
Where it was distributed
US Distribution to states of: IL, MO, NE, and OH.
Questions about this recall
Why was it recalled?
Powdered Surgical Gloves are an FDA banned substance.
Which lots are affected?
Tray Number (Powdered Glove code): MHCE23D (ANS5711104), MHAP41D (ANS7825), MHOC43C (ANS7825), MHPO42D (ANS7825), GVTH071 (ANS5711104), GVTK05L (ANS5711104), GVTK05M (ANS5711104), CXTR68D (ANS5711105), MDEY35H (BAX2D7202I), MDEY35I (BAX2D7202I), FHLV24 (ANS5711105, ANS5711101), LKCA02A (ANS5710503), WIDE32 (ANS7824), UTLU70F (ANS7825), FIOH02H (BAX2D7254)
Where was it sold?
US Distribution to states of: IL, MO, NE, and OH.
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.
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