Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Complete recall history across all FDA and CPSC categories — 18 total recalls

Recall Summary

4 Drug Recalls 14 Device Recalls

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company appears in recall records across 2 categories. 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.

Drug Recalls (4)

FDA drug safety enforcement actions by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Date Product Reason Class
Sep 5, 2017 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. ... Lack of sterility assurance: leaking containers which could lead to exposure... Class II
Sep 5, 2017 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz.... Lack of sterility assurance: leaking containers which could lead to exposure... Class II
Sep 5, 2017 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz.... Lack of sterility assurance: leaking containers which could lead to exposure... Class II
Sep 5, 2017 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. ... Lack of sterility assurance: leaking containers which could lead to exposure... Class II

Device Recalls (14)

FDA medical device enforcement actions by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Date Product Reason Class
Sep 5, 2017 Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 Lack of sterility assurance: leaking containers which could lead to exposure ... Class II
Sep 5, 2017 Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Medline Prefilled 550 ml Sterile¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Portex Unit Dose 15 ml Normal Saline ¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I
Sep 5, 2017 Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure... Class I

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.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.

Food Firms Drug Firms Device Firms Product Manufacturers