Baxter Healthcare Corp.

Complete recall history across all FDA and CPSC categories — 126 total recalls

Recall Summary

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 (52)

FDA drug safety enforcement actions by Baxter Healthcare Corp.. Showing most recent 50.

Date	Product	Reason	Class
Apr 12, 2016	Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium...	Discoloration: presence of atypical yellow discoloration of the solution .	Class II
Feb 5, 2016	0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthca...	PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particu...	Class II
Jan 21, 2016	CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose...	Presence of Particulate Matter: identified as dried skin.	Class I
Jan 21, 2016	0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S...	Lack of Assurance of Sterility: potential for leaking containers which lacks ...	Class II
Jan 21, 2016	0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S...	Presence of Particulate Matter: identified as cardboard.	Class I
Jan 21, 2016	Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Singl...	Presence of Particulate Matter: identified as a cloth fiber.	Class I
Dec 15, 2015	Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bu...	Presence of Particulate Matter: Confirmed customer compliants of finding an i...	Class I
Dec 15, 2015	0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx...	Presence of Particulate Matter: Confirmed customer compliants of finding an i...	Class I
Jul 17, 2015	0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si...	Presence of Particulate Matter: Customer complaint for an insect found free f...	Class I
Jul 17, 2015	0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags,...	Presence of Particulate Matter: Customer complaint for an insect found free f...	Class I
Jul 2, 2015	0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxt...	Presence of Particulate Matter and Lack of Assurance of Sterility: The firm r...	Class II
Mar 24, 2015	10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Bax...	Presence of Particulate Matter: Products recalled due to presence of particu...	Class I
Mar 24, 2015	Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by ...	Presence of Particulate Matter: Products recalled due to presence of particu...	Class I
Mar 24, 2015	5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxte...	Presence of Particulate Matter: Products recalled due to presence of particu...	Class I
Mar 24, 2015	0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactu...	Presence of Particulate Matter: Products recalled due to presence of particu...	Class I
Mar 18, 2015	0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx ...	Lack of Assurance of Sterility. Complaints were receive of missing closures a...	Class II
Mar 18, 2015	5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Man...	Lack of Assurance of Sterility. Complaints were receive of missing closures a...	Class II
Dec 23, 2014	Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRA...	Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal...	Class II
Nov 25, 2014	Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De...	Lack of Assurance of Sterility; leaks were observed from the bag seam and por...	Class II
Nov 10, 2014	Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose con...	Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq...	Class II
Oct 30, 2014	Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500...	Subpotent Drug: Heparin raw material was found to have low potency	Class II
Sep 29, 2014	DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, ...	Lack of Assurance of Sterility: A small cut in the solution bag may have been...	Class II
Aug 7, 2014	Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro...	Presence of Particulate Matter: particulate matter was found during the manuf...	Class I
Jul 30, 2014	0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxte...	Lack of Assurance of Sterility; complaints of mold in the overpouch	Class II
Jul 11, 2014	0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container ba...	Presence of Particulate Matter: particulate matter identified as fibers and/o...	Class I
Jul 11, 2014	Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Con...	Presence of Particulate Matter: particulate matter identified as fibers and/o...	Class I
Jul 11, 2014	0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si...	Presence of Particulate Matter: particulate matter identified as fibers and/o...	Class I
Jun 16, 2014	Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500...	Presence of Particulate Matter: Complaints received of discolored solution id...	Class II
May 12, 2014	0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, B...	Presence of Particulate Matter; blue polyisoprene shavings found inside the b...	Class I
Apr 24, 2014	Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G342...	Presence of Particulate Matter: Baxter Healthcare Corporation has received a ...	Class II
Apr 21, 2014	0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufacture...	Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium...	Class II
Feb 11, 2014	Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Fl...	Non-Sterility: Complaints of leaks and particulate matter identified as mold ...	Class I
Nov 21, 2013	0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX...	Presence of Particulate Matter: Baxter is issuing a voluntary recall for thes...	Class I
Nov 21, 2013	5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx...	Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these...	Class I
Nov 18, 2013	Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1...	Presence of Particulate Matter: Particulate matter includes wood, sodium citr...	Class I
Nov 18, 2013	Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De...	Presence of Particulate Matter: Particulate matter includes wood, sodium citr...	Class I
Nov 18, 2013	Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL...	Presence of Particulate Matter: Particulate matter includes wood, sodium citr...	Class I
Nov 18, 2013	50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass conta...	Presence of Particulate Matter; particulate matter in one vial identified as ...	Class I
Nov 12, 2013	10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for ...	Lack of Assurance of Sterility; Drug product leaking from container therefore...	Class II
Jul 24, 2013	DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro...	Defective Container: There is a potential for frangible components to be brok...	Class II
May 21, 2013	Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 20...	Lack of Assurance of Sterility: Specific lot numbers of these products have b...	Class II
May 21, 2013	0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (ND...	Lack of Assurance of Sterility: Specific lot numbers of these products have b...	Class II
May 21, 2013	Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Bax...	Lack of Assurance of Sterility: Specific lot numbers of these products have b...	Class II
May 21, 2013	5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only,...	Lack of Assurance of Sterility: Specific lot numbers of these products have b...	Class II
May 21, 2013	Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plast...	Lack of Assurance of Sterilty: Specific lot numbers of these products have be...	Class II
May 21, 2013	Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Cont...	Lack of Assurance of Sterility: Specific lot numbers of these products have b...	Class II
Feb 27, 2013	0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, ...	Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% S...	Class II
Sep 21, 2012	0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, pr...	Chemical Contamination: The IV solutions were packaged in AVIVA containers wh...	Class II
Sep 21, 2012	5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVI...	Chemical Contamination: The IV solutions were packaged in AVIVA containers wh...	Class II
Sep 21, 2012	5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product cod...	Chemical Contamination: The IV solutions were packaged in AVIVA containers wh...	Class II

View all 52 drug recalls →

Device Recalls (74)

FDA medical device enforcement actions by Baxter Healthcare Corp.. Showing most recent 50.

Date	Product	Reason	Class
Oct 12, 2016	GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1...	Potential presence of particulate matter on the blood side of the dialyzer	Class II
Sep 28, 2016	Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum In...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug...	Class II
Sep 28, 2016	sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug...	Class II
Sep 28, 2016	V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA S...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug...	Class II
Jun 24, 2016	Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod...	Baxter is issuing a safety alert in response to postmarketing reports receive...	Class II
May 23, 2016	PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy	Presence of leaks near top of the PrismaSate bags	Class II
Apr 21, 2016	GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2...	Instructions for use booklet may puncture the outer Tyvek lid.	Class II
Apr 21, 2016	GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2...	Instructions for use booklet may puncture the outer Tyvek lid.	Class II
Apr 21, 2016	GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2...	Instructions for use booklet may puncture the outer Tyvek lid.	Class II
Apr 21, 2016	GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2...	Instructions for use booklet may puncture the outer Tyvek lid.	Class II
Apr 21, 2016	GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2...	Instructions for use booklet may puncture the outer Tyvek lid.	Class II
Feb 16, 2016	Automated peritoneal dialysis (APD) cycler	Baxter Healthcare Corporation is sending this communication to inform you of ...	Class II
Nov 30, 2015	Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: F...	Potential for dark loose particulate matter (400 microns or smaller) on the s...	Class II
Nov 30, 2015	Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I....	Potential for dark loose particulate matter (400 microns or smaller) on the s...	Class II
Nov 30, 2015	Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, ...	Potential for dark loose particulate matter (400 microns or smaller) on the s...	Class II
Oct 6, 2015	Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path	Leakage from the inlet port of the 15L Cycler Drainage Bags.	Class II
Jun 29, 2015	Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automat...	Loud operating sounds, which was unacceptable to the end users when the devic...	Class III
Jan 22, 2015	MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.	Product may have separating or protruding sponges	Class II
Jan 14, 2015	Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Pla...	Potential for failure of the pouch packaging seal at high altitudes.	Class II
Dec 8, 2014	Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid ...	Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dia...	Class II
Oct 21, 2014	HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal...	The keypad buttons on HomeChoice devices may be activated without the operato...	Class II
Oct 6, 2014	HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter'...	There are additional and updated warning and cautions that are not in the Pat...	Class II
Sep 3, 2014	SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled...	One Service Technician may not have correctly serviced specific Sigma Spectru...	Class II
Jun 17, 2014	Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corp...	Inadequate iodine and packaging related defects.	Class II
Jun 10, 2014	EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-...	If the universal ingredient (UI) in an active configuration is changed using ...	Class II
Apr 24, 2014	Baxter Amia Automated PD systems are used in the treatment of adult renal fai...	System error 01779 is produced when the battery cannot be charged due to spec...	Class II
Apr 17, 2014	The Patient Control Module (PCM) is used in conjunction with a Baxter infusor...	Potential for device malfunction resulting in flow when the device should not...	Class II
Apr 3, 2014	AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for p...	Additional warning in the AMIA APD System labeling for patients vulnerable to...	Class II
Feb 7, 2014	SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U...	Baxter Healthcare Corporation has issued an Urgent Device Correction for the ...	Class I
Nov 8, 2013	IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syrin...	Following a retrospective review for Baxter Daytona Complaint CR-954, it was ...	Class II
Oct 16, 2013	The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeCho...	The occluder in affected devices 1) may have sharp edges that could cut the p...	Class II
Oct 7, 2013	1) The HomeChoice automated peritoneal dialysis system. Dataplate located on...	In systems with version 10.4 software Initial Drain logic, the device will at...	Class II
Sep 25, 2013	Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corp...	Incomplete foil seal on one lot of sterile product.	Class II
Sep 24, 2013	SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD sc...	Baxter Healthcare Corporation is recalling the LCD display screen on the SIGM...	Class II
Sep 10, 2013	Dual Luer Lock Cap The device is intended for use as a cap for male or fem...	The firm is recalling lots 10043 and 10044 due to loose particulate matter fo...	Class II
Sep 4, 2013	Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ...	The firm is issuing a voluntary recall due to the potential for pinholes in t...	Class II
Aug 30, 2013	Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured ...	Potential tears in the pouch of six lots of Vented Spike Adapter Product Code...	Class II
Jul 8, 2013	Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.	the white printed paper layer on the pouch packaging may not be fully adhere...	Class II
Jun 10, 2013	SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used...	Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGM...	Class II
Jun 7, 2013	Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administrat...	Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall fo...	Class II
Jun 7, 2013	Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for ...	Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall fo...	Class II
Jun 7, 2013	Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous ...	Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall fo...	Class II
Jun 7, 2013	Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor:...	Due to an increase in complaints for leaks at the distal male Luer and Luer c...	Class II
Jun 7, 2013	Brand Name: Multirate Infusor Devices. Indicated for the intravenous admin...	Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall fo...	Class II
Jun 7, 2013	Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Bax...	Due to an increase in complaints for leaks at the distal male Luer and Luer c...	Class II
Jun 7, 2013	Brand Name: Intermate Infusion Pump. Indicated for the intravenous adminis...	Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall fo...	Class II
Jun 7, 2013	Brand Name: Regional Analgesia Infusor System with Patient Control. Indica...	Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall fo...	Class II
Jun 7, 2013	Brand Name: Intermate Infusion Pump. Indicated for the intravenous adminis...	Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall fo...	Class II
May 21, 2013	Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Cor...	leaking pouches	Class II
May 15, 2013	Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Conta...	A firm's internal investigation led to the discovery of pinholes in the packa...	Class II

View all 74 device recalls →

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