Bausch & Lomb Inc

Complete recall history across all FDA and CPSC categories — 17 total recalls

Bausch & Lomb 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 (17)

FDA medical device enforcement actions by Bausch & Lomb Inc

Date Product Reason Class
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II
Nov 4, 2014 Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Ba... A software anomaly was identified where the system may automatically transiti... Class II
Nov 4, 2014 Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Softwar... A software anomaly was identified where the system may automatically transiti... Class II
Nov 4, 2014 Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Softwa... A software anomaly was identified where the system may automatically transiti... Class II
Aug 31, 2012 Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Modu... Posterior fluidics modules installed in the system may need to be recalibrated. 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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