CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report
Artelon FlexBand Plus recalled by International Life Sciences
International Life Sciences is recalling Artelon FlexBand Plus, distributed nationwide in the US. The recall was initiated on 6 Feb 2026 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-1555-2026
- FDA event ID
- 98399
- Recalling firm
- International Life Sciences, Atlanta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Feb 2026
- FDA classified
- 11 Mar 2026
- Reported
- 18 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Feb 2026 | Recall initiated by company | |
| 11 Mar 2026 | Classified by FDA | +33 days |
| 18 Mar 2026 | 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
Augmentation devices failed bacterial endotoxin testing.
Product as listed by the FDA
Artelon FlexBand Plus Ref: 41054 & 41057
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Augmentation devices failed bacterial endotoxin testing.
Which lots are affected?
REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
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
2 other products · FDA event 98399This product is part of a recall event; the main page for the event is Artelon FlexBand Dynamic Matrix recalled by International Life Sciences.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Artelon FlexBand Dynamic Matrix recalled by International Life Sciences | International Life Sciences | Other | Nationwide | |
| CLASS II | Artelon Flexband Twist .12 recalled by International Life Sciences | International Life Sciences | Other | Nationwide |
More recalls from International Life Sciences
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artelon Flexband Twist .12 recalled by International Life Sciences | International Life Sciences | Other | Nationwide |
| Device | CLASS II | Artelon FlexBand Dynamic Matrix recalled by International Life Sciences | International Life Sciences | Other | Nationwide |
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