Pro-Dex Inc

Complete recall history across all FDA and CPSC categories — 6 total recalls

Pro-Dex 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 (6)

FDA medical device enforcement actions by Pro-Dex Inc

Date Product Reason Class
Sep 23, 2024 KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40),... The packaging of a sterile battery, intended to power a surgical screwdriver,... Class II
Feb 15, 2023 KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), u... Battery packs used in surgical procedures where a surgeon uses a powered scre... Class II
Feb 14, 2023 KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter... Incorrect Unique Device Identifier/GTIN code was used on product. Class II
Sep 25, 2018 PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, S... Visual particulates within a battery Tyvek pouch. The battery is provided st... Class II
Dec 23, 2015 Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power ... The sterile battery may contain particulates within the sterile package. Class II
Dec 23, 2015 Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS ... The sterile battery may contain particulates within the sterile package. 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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