Aspen Surgical Products, Inc.
Aspen Surgical Products, Inc. has 3 FDA enforcement events on this register (23 product records) between 2013 and 2021: 3 device; the busiest year was 2013 with 1.
0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in MI.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 23 Jul 2021 | Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300 | Device | Class II | 3 | Terminated |
| 20 Mar 2014 | 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage | Device | Class II | 19 | Terminated |
| 18 Jul 2013 | Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5… | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Aspen Surgical Products, Inc. had?
3 enforcement events (23 product records) on this register, 2013–2021: 3 device.
Are any Aspen Surgical Products, Inc. recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Aspen Surgical Products, Inc. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.