CLASS II Device recall · Reported 8 Sep 2021 · FDA Enforcement Report
Jessie Sterile Arm Suspension Kit, Product recalled
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kit, distributed nationwide in the US. The recall was initiated on 23 Jul 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-2388-2021
- FDA event ID
- 88476
- Recalling firm
- Aspen Surgical Products, Caledonia, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jul 2021
- FDA classified
- 30 Aug 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Jul 2021 | Recall initiated by company | |
| 30 Aug 2021 | Classified by FDA | +38 days |
| 8 Sep 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Where it was distributed
US nationwide distribution. No foreign distribution.
Questions about this recall
Why was it recalled?
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Which lots are affected?
All lots manufactured between July 9, 2019 to July 9, 2021
Where was it sold?
US nationwide distribution. No foreign distribution.
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 88476This product is part of a recall event; the main page for the event is Norton Arm Kit, Product recalled by Aspen Surgical Products.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Norton Arm Kit, Product recalled by Aspen Surgical Products | Aspen Surgical Products | Sterility | Nationwide | |
| CLASS II | Marco Shoulder Stabilization Kit, Product recalled | Aspen Surgical Products | Sterility | Nationwide |
More recalls from Aspen Surgical Products
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Marco Shoulder Stabilization Kit, Product recalled | Aspen Surgical Products | Sterility | Nationwide |
| Device | CLASS II | Norton Arm Kit, Product recalled by Aspen Surgical Products | Aspen Surgical Products | Sterility | Nationwide |
| Device | CLASS II | Drain Kit Full Fluted with Trocar and S-Vac Bulb recalled | Aspen Surgical Products | Sterility | 35 states |
| Device | CLASS II | Drain Kit Flat Full Perforated with Trocar, Saber Bulb recalled | Aspen Surgical Products | Sterility | 35 states |
| Device | CLASS II | Drain Kit Flat Full Perforated with Trocar recalled | Aspen Surgical Products | Sterility | 35 states |
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|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | 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 II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| 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 | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |