DeviceSignal · Recall classified
Medical Action Industries, Inc. 306
FDA classified a device recall on 2026-09-09 · Class I · Z-3107-2026
EventRecall classified
Effective2026-09-09
ClassificationClass I
On 2026-09-09 the FDA classified a device recall from Medical Action Industries, Inc. 306 as Class I. Product: Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF…. Recall Z-3107-2026. The firm initiated it on 2026-07-23. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3107-2026
- Classification
- Class I
- Classified on
- 2026-09-09
- Initiated on
- 2026-07-23
- Firm
- Medical Action Industries, Inc. 306
- Reason
- Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
- Product
- Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3107-2026- Snapshot hash
e8e634c086f9f5f52e82a7eef6331d8800209bbb8cbb79bd654d29f1222caae4- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
d61c0ef1ab5d857663360e0c5a9da733a8d70e275f5d409e796335bc50de44ec- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)