Manufacturer

Aspen Surgical Products, Inc.

23 recalls in our database name Aspen Surgical Products, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 23
Critical: 0
Severe: 0
Most recent: 2021-09-08

Of the 23 recalls from Aspen Surgical Products, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–23 of 23

HighFDA (Devices)·Z-2389-2021·2021-09-08
Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure
Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.
Product
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2388-2021·2021-09-08
Surgical arm suspension kits recalled due to sterilization concerns
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.
Product
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2390-2021·2021-09-08
Norton Arm Kit surgical device recall due to sterilization failure
Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.
Product
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2014·2014-04-16
Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns
Aspen Surgical Products is recalling wound drainage kits due to a potential compromise of the sterile barrier, posing a risk of infection.
Product
10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1424-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1434-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Product
7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1422-2014·2014-04-16
Aspen Surgical Recalls Sterile Bulb Evacuator Due to Sterility Concerns
Aspen Surgical Products is recalling sterile bulb evacuators because the sterile barrier may be compromised, potentially increasing infection risk.
Product
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1435-2014·2014-04-16
Aspen Surgical Recalls Sterile Drain Kits Due to Sterility Compromise
Aspen Surgical Products is recalling specific sterile drain kits and bulb evacuators because the sterile barrier may be compromised.
Product
7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case)
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1418-2014·2014-04-16
Aspen Surgical 10mm Drain Kit Recalled for Sterile Barrier Compromise
Aspen Surgical Products is recalling 10mm Drain Kits due to a potential compromise of the sterile barrier, posing a risk of infection.
Product
10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1430-2014·2014-04-16
Aspen Surgical Products Recalls Sterile Wound Drainage Kits
Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.
Product
7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1429-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Product
10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1426-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, posing a risk of infection.
Product
19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1423-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1421-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Devices Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage devices due to a potential compromise of the sterile barrier.
Product
Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1432-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Product
15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1417-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling 7mm Drain Kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1425-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1431-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1433-2014·2014-04-16
Aspen Surgical Products Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.
Product
19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1419-2014·2014-04-16
Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns
Aspen Surgical Products is recalling specific wound drainage kits due to a potential compromise of the sterile barrier.
Product
10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1428-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.
Product
10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1420-2014·2014-04-16
Aspen Surgical Products Recalls Sterile Wound Drainage Kits
Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.
Product
15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1988-2013·2013-08-28
Aspen Surgical Recalls Wound Closures Due to Sterility Concerns
Aspen Surgical Products is recalling reinforced wound closure strips because FDA sampling indicated the product may not be sterile, posing a risk of infection.
Product
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,
Category
Medical Device
Distribution
Distributed nationwide