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Aspen Surgical Products, Inc.

Complete recall history across all FDA and CPSC categories — 23 total recalls

Aspen Surgical Products, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (23)

FDA medical device enforcement actions by Aspen Surgical Products, Inc.

Date Product Reason Class
Jul 23, 2021 Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code... Affected products were manufactured with materials found to have a bioburden ... Class II
Jul 23, 2021 Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product cod... Affected products were manufactured with materials found to have a bioburden ... Class II
Jul 23, 2021 Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample K... Affected products were manufactured with materials found to have a bioburden ... Class II
Mar 20, 2014 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSyste... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuato... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C Sys... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile ... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile ... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C Sys... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (1... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuato... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intend... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) In... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Mar 20, 2014 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile ba... Class II
Jul 18, 2013 Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late... Aspen Surgical is recalling Wound Closures because firm could not confirm ste... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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