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Salter Labs

Complete recall history across all FDA and CPSC categories — 5 total recalls

Salter Labs 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 (5)

FDA medical device enforcement actions by Salter Labs

Date Product Reason Class
Jan 5, 2016 T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single pat... Reports that the T-piece does not fit on the nebulizer. Class II
Aug 4, 2015 NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebuli... The Inspiratory valve cap on the nebulizer reservoir tower may be loose and m... Class II
Jun 25, 2014 Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentrat... The case label correctly states partial rebreather but the insert label incor... Class II
Nov 1, 2013 Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx onl... It has been determined that three lots of model number 4515-15-25 CO2 Sample ... Class II
May 30, 2012 Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 f... A complaint was received, and later verified, that product labeled as SO-1296... 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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