PlainRecalls

Baxter Healthcare Corporation

Compiled from official public sources by the editorial team.

405 recalls on record · Latest: Apr 8, 2026

Baxter Healthcare Corporation Recall Insight

Baxter Healthcare Corporation appears on 405 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.398% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 8, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 4 critical, 44 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 49 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 2 distinct product categories, with issuing agencies dominated by FDA Devices (45), FDA Drug (5). The date window on this page runs from Jan 2, 2019 to Feb 10, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 10, 2021

FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.

FDA Devices Moderate Jan 20, 2021

VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for …

FDA Devices Moderate Jan 13, 2021

MiniCap Extended Life PD Transfer Set

FDA Devices Moderate Dec 30, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fl…

FDA Devices Moderate Dec 30, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fl…

FDA Devices Moderate Dec 30, 2020

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.

FDA Devices Moderate Dec 30, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fl…

FDA Drug Moderate Nov 18, 2020

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter…

FDA Devices Critical Oct 28, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

FDA Devices Critical Oct 28, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

FDA Devices Critical Oct 28, 2020

Spectrum IQ Infusion System with Dose IQ Safety Software

FDA Devices Critical Oct 28, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

FDA Devices Moderate Jul 8, 2020

Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

FDA Devices Moderate Jun 10, 2020

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysi…

FDA Devices Moderate Jun 10, 2020

Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

FDA Devices Moderate Jun 10, 2020

Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dial…

FDA Devices Moderate Jun 10, 2020

Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment…

FDA Devices Moderate May 27, 2020

Prismaflex Control Unit

FDA Devices Moderate May 6, 2020

Prismaflex System, Prismaflex Control Unit

FDA Devices Moderate May 6, 2020

Prismaflex System, Prismaflex Control Unit

FDA Devices Moderate May 6, 2020

Prismaflex System, Prismaflex Control Unit

FDA Devices Moderate May 6, 2020

Prismaflex System, Prismaflex Control Unit

FDA Devices Moderate May 6, 2020

Prismaflex System, Prismaflex Control Unit

FDA Devices Moderate May 6, 2020

Prismaflex System, Prismaflex Control Unit

FDA Devices Moderate Apr 15, 2020

GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in…

FDA Devices Moderate Apr 15, 2020

GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical pr…

FDA Devices Moderate Apr 15, 2020

GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered i…

FDA Devices Moderate Mar 11, 2020

Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

FDA Devices Moderate Jan 15, 2020

Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a …

FDA Devices Moderate Jan 15, 2020

ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N837…

FDA Drug Moderate Nov 27, 2019

0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29

FDA Devices Moderate Nov 13, 2019

Prismaflex Control Unit, software versions below 7.21

FDA Devices Moderate Nov 13, 2019

Prismaflex Control Unit, software versions below 7.21

FDA Devices Moderate Nov 13, 2019

Prismaflex Control Unit, software versions below 7.21

FDA Devices Moderate Nov 13, 2019

Prismaflex Control Unit, software versions below 7.21

FDA Devices Moderate Nov 13, 2019

Prismaflex Control Unit, software versions below 7.21

FDA Devices Moderate Nov 6, 2019

TherMax Blood Warmer Unit

FDA Devices Moderate Oct 30, 2019

EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3.…

FDA Devices Low Oct 16, 2019

EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H938…

FDA Devices Moderate Oct 9, 2019

L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

FDA Devices Low Sep 4, 2019

EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500

FDA Drug Moderate Jul 31, 2019

0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

FDA Devices Moderate Jul 10, 2019

REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal fai…

FDA Devices Moderate Jul 10, 2019

REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal fai…

FDA Drug Moderate Jun 19, 2019

Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651…

FDA Devices Moderate May 8, 2019

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion P…

FDA Devices Moderate Feb 27, 2019

Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment …

FDA Devices Moderate Feb 27, 2019

AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment o…

FDA Drug Moderate Jan 16, 2019

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporati…

FDA Devices Moderate Jan 2, 2019

GEM Coupler Forceps, GEM4183C, packaged individually.

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.