CLASS II Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
Medical Action Industries INC., General Purpose Instrument Tray recalled
Medical Action Industries Inc. 306 is recalling Medical Action Industries INC., General Purpose Instrument Tray, distributed nationwide in the US. The recall was initiated on 11 May 2021 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-1948-2021
- FDA event ID
- 87954
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2021
- FDA classified
- 24 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 11 May 2021 | Recall initiated by company | |
| 24 Jun 2021 | Classified by FDA | +44 days |
| 30 Jun 2021 | 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
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
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
Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
Where it was distributed
US Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIllinoisLouisianaMassachusettsMarylandMinnesotaNew YorkOregonTexasVirginiaWashington
Questions about this recall
Why was it recalled?
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Which lots are affected?
Batch Numbers: 0000277610, Exp. 04/15/2022; 0000276879, Exp. 04/15/2022
Where was it sold?
US Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.
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.
Other products in this recall event
4 other products · FDA event 87954This product is part of a recall event; the main page for the event is novaplus, General Purpose Kit recalled by Medical Action Industries.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | novaplus, General Purpose Kit recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Foreign Material | Nationwide | |
| CLASS II | Medical Action Industries INC., Minor Procedure Tray recalled | Medical Action Industries Inc. 306 | Foreign Material | Nationwide | |
| CLASS II | Medical Action Industries INC. recalled | Medical Action Industries Inc. 306 | Foreign Material | Nationwide | |
| CLASS II | Medical Action Industries INC. recalled | Medical Action Industries Inc. 306 | Foreign Material | Nationwide |
More recalls from Medical Action Industries Inc. 306
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Blood Culture Collection Venipuncture Kit 20/Cs recalled | Medical Action Industries Inc. 306 | Sterility | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Medical Action Industries Dialysis Change Tray Clear Sequence recalled | Medical Action Industries Inc. 306 | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |