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Baxter Healthcare Corp

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

Recall Summary

6 Drug Recalls 12 Device Recalls

Baxter Healthcare Corp 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 (6)

FDA drug safety enforcement actions by Baxter Healthcare Corp

Date Product Reason Class
Jun 3, 2015 Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 50... Subpotent Drug; out of specification results for heparin raw material Class II
Mar 23, 2015 Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose... Lack of Assurance of Sterility; increased complaints received for leaks Class II
Mar 23, 2015 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi P... Lack of Assurance of Sterility; increased complaints received for leaks Class II
Dec 4, 2014 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, ... Presence of Particulate Matter: Confirmed customer complaints received for t... Class I
Sep 8, 2014 Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq... Correct Labeled Product Mispack: Shipping cartons labeled as containing Potas... Class II
Aug 4, 2014 ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container ... Presence of Particulate Matter: identification of particulates in a retention... Class II

Device Recalls (12)

FDA medical device enforcement actions by Baxter Healthcare Corp

Date Product Reason Class
Sep 1, 2017 Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 The firm received increased customer complaints for Missing Red Line, Patient... Class II
May 12, 2016 COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular ... Potential for incomplete dissolution of the polyethylene glycol (PEG) compone... Class II
May 12, 2016 COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular... Potential for incomplete dissolution of the polyethylene glycol (PEG) compone... Class II
May 12, 2016 COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular... Potential for incomplete dissolution of the polyethylene glycol (PEG) compone... Class II
May 21, 2015 ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONN... Potential for a leak at the tubing to luer bond. Class II
Mar 2, 2015 Master Drug Library Software version 8.0, Product Code 35723V080, to be used ... Loading/Bolus default dose settings in the Master Drug Library and the values... Class II
Sep 16, 2014 Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ... Particulate matter found inside the fluid path. Class I
Sep 16, 2014 Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen... Particulate matter found inside the fluid path. Class I
Jul 14, 2014 ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamb... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lo... Class II
Jul 14, 2014 ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lo... Class II
Jul 14, 2014 ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Cham... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lo... Class II
Oct 17, 2013 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubin... The large tube clamp used to close the drain tube on the 15 L Cycler Drainage... 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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