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Breg Inc

Complete recall history across all FDA and CPSC categories — 13 total recalls

Breg 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 (13)

FDA medical device enforcement actions by Breg Inc

Date Product Reason Class
Sep 13, 2023 BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walkin... Due to walkers not meeting product specifications. Walkers were manufactured... Class II
Mar 30, 2017 If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products ar... They may not have been sealed prior to sterilization. Products with unsealed... Class II
Mar 30, 2017 Dressing Rect L, P/N 02428 Product Usage: These products are sterile dres... They may not have been sealed prior to sterilization. Products with unsealed... Class II
Mar 30, 2017 Dressing Shldr, P/N 04908 Product Usage: These products are sterile dress... They may not have been sealed prior to sterilization. Products with unsealed... Class II
Mar 30, 2017 Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile ... They may not have been sealed prior to sterilization. Products with unsealed... Class II
Mar 30, 2017 Dressing Back, P/N 09810 Product Usage: These products are sterile dressi... They may not have been sealed prior to sterilization. Products with unsealed... Class II
Mar 30, 2017 Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile ... They may not have been sealed prior to sterilization. Products with unsealed... Class II
Mar 30, 2017 Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dres... They may not have been sealed prior to sterilization. Products with unsealed... Class II
Mar 30, 2017 Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dr... They may not have been sealed prior to sterilization. Products with unsealed... Class II
Mar 14, 2014 K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The prod... Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stay... Class II
Mar 14, 2014 Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usa... Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stay... Class II
Jan 14, 2013 BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev ... The recall was initiated because Breg has determined that some Sterile Polar ... Class II
Jan 14, 2013 BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode... The recall was initiated because Breg has determined that some Sterile Polar ... 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.

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