CLASS II Device recall · Reported 27 Jan 2016 · FDA Enforcement Report
Accusorb MRI MAC7002 recalled by MWT Materials
MWT Materials is recalling Accusorb MRI MAC7002, distributed nationwide in the US. The recall was initiated on 6 Oct 2014 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-0664-2016
- FDA event ID
- 72202
- Recalling firm
- MWT Materials, Passaic, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2014
- FDA classified
- 20 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 6 Oct 2014 | Recall initiated by company | |
| 20 Jan 2016 | Classified by FDA | +471 days |
| 27 Jan 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Product as listed by the FDA
Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Where it was distributed
US Nationwide Distribution in the states of NY and MA.
Questions about this recall
Why was it recalled?
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Which lots are affected?
All
Where was it sold?
US Nationwide Distribution in the states of NY 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.
Other products in this recall event
10 other products · FDA event 72202This product is part of a recall event; the main page for the event is Accusorb MRI MAC7007 recalled by MWT Materials.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Accusorb MRI MAC7007 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7009 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7006 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7004 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7030 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7008 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7005 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7001 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7003 recalled by MWT Materials | MWT Materials | Other | Nationwide | |
| CLASS II | Accusorb MRI MAC7010 recalled by MWT Materials | MWT Materials | Other | Nationwide |
More recalls from MWT Materials
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Accusorb MRI MAC7010 recalled by MWT Materials | MWT Materials | Other | Nationwide |
| Device | CLASS II | Accusorb MRI MAC7003 recalled by MWT Materials | MWT Materials | Other | Nationwide |
| Device | CLASS II | Accusorb MRI MAC7001 recalled by MWT Materials | MWT Materials | Other | Nationwide |
| Device | CLASS II | Accusorb MRI MAC7005 recalled by MWT Materials | MWT Materials | Other | Nationwide |
| Device | CLASS II | Accusorb MRI MAC7008 recalled by MWT Materials | MWT Materials | Other | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |