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Southmedic, Inc.

Complete recall history across all FDA and CPSC categories — 4 total recalls

Southmedic, 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 (4)

FDA medical device enforcement actions by Southmedic, Inc.

Date Product Reason Class
Oct 27, 2022 Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020,... Upon review of its batch record, Southmedic identified that lot # W92761 was ... Class II
May 25, 2021 OxyMask O2 Adult REF OM-1125-14 Potential for oxygen tubing to disconnect from mask or loosen. Disconnecte... Class II
Nov 6, 2017 Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be ... Scalpels lot contains non-sterile products labeled as sterile. Class II
Oct 17, 2017 Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 ma... Potential for loose or missing CO2 diffusers which could result in a non-func... 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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