thejoe Baxter Healthcare Corporation

Baxter Healthcare Corporation: 375 FDA recall reports

Every medical device recall the FDA has published for Baxter Healthcare Corporation. The fault, and how the agency graded it.

375Reports

68Class I

272Ongoing

2026-07-08Most recent

68 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	304
Class I	68
Class III	3

By year reported

Year	Reports
2012	1
2014	1
2017	7
2018	29
2019	16
2020	26
2021	26
2022	74
2023	21
2024	93
2025	71
2026	10

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Class I

Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillat

Z-2550-2026 · Class I · reported 2026-07-08 · Ongoing

Why it was recalled: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Product: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
Where it went: Worldwide distribution - US Nationwide and the country of Canada.
How much: 16187 units

Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of t

Z-2638-2026 · Class II · reported 2026-07-08 · Ongoing

Why it was recalled: The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.
Product: Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
Where it went: Worldwide - US Nationwide distribution in the states of Minnesota, Maryland, and Pennsylvania and the countries of Canada, Hong Kong, India, Japan, Korea, Philippines, Taiwan, Thailand, Vietnam, Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iraq, Israel, Italy, Jordan, Kenya, Lebanon, Libya, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arabia Emrites, Ukraine, Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru.
How much: 13 units

Class I

Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscill

Z-2551-2026 · Class I · reported 2026-07-08 · Ongoing

Why it was recalled: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Product: Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Where it went: Worldwide distribution - US Nationwide and the country of Canada.
How much: 13881 units

Class I

Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation

Z-2548-2026 · Class I · reported 2026-07-08 · Ongoing

Why it was recalled: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Product: Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Where it went: Worldwide distribution - US Nationwide and the country of Canada.
How much: 10540 units

Class I

Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillatio

Z-2549-2026 · Class I · reported 2026-07-08 · Ongoing

Why it was recalled: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Product: Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Where it went: Worldwide distribution - US Nationwide and the country of Canada.
How much: 0

Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Des

Z-2262-2026 · Class II · reported 2026-06-10 · Ongoing

Why it was recalled: Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
Product: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.
Where it went: Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. The countries of Taiwan and Uruguay.
How much: 105675

Class I

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara R

Z-1637-2026 · Class I · reported 2026-04-08 · Ongoing

Why it was recalled: Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
Product: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Where it went: Florida
How much: 19 units

Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS1

Z-1573-2026 · Class II · reported 2026-03-25 · Ongoing

Why it was recalled: Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Product: Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
Where it went: Worldwide - US Nationwide distribution in the states of AZ, CO, IL, IN, KS, MA, NE, NJ, NM, NY, PA, SC, TX, VA and the countries of Colombia and India.
How much: 59

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Pr

Z-1368-2026 · Class II · reported 2026-02-25 · Ongoing

Why it was recalled: Pumps were released without full testing being performed, including occlusion alarm testing.
Product: Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Where it went: States: Ohio Countries: United States
How much: 5

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

Z-1121-2026 · Class II · reported 2026-01-28 · Ongoing

Why it was recalled: Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
Product: SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Where it went: US Nationwide distribution.
How much: 585 units

Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Wel

Z-0847-2026 · Class II · reported 2025-12-10 · Ongoing

Why it was recalled: Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Product: Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Where it went: US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
How much: 118 units

Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-20

Z-0233-2026 · Class II · reported 2025-10-29 · Ongoing

Why it was recalled: Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
Product: Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
Where it went: Distribution US nationwide, Canada and Colombia.
How much: 5209

CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Pr

Z-0190-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 136512

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve,

Z-0194-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 1167120

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves,

Z-0195-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 106176

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Re

Z-0198-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 2304

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve,

Z-0193-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 958351

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve,

Z-0202-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 12720

CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519

Z-0204-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 18720 units

CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve,

Z-0203-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 27072

CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcoc

Z-0189-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 49200

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, R

Z-0197-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 15552

CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEA

Z-0200-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 69936

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 1

Z-0192-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 473040

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valve

Z-0196-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 8368

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-in

Z-0201-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 48096

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, R

Z-0199-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 16416

CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 met

Z-0191-2026 · Class II · reported 2025-10-22 · Ongoing

Why it was recalled: IV sets may leak.
Product: CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Where it went: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
How much: 1440

Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL.

Z-2594-2025 · Class II · reported 2025-10-01 · Ongoing

Why it was recalled: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
Product: Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
Where it went: US Nationwide distribution.
How much: 14400 units

Class I

Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump

Z-2333-2025 · Class I · reported 2025-09-10 · Ongoing

Why it was recalled: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Product: Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Where it went: US distribution including Puerto Rico and OUS (International) Canada
How much: 10,101 units

Showing the 30 most recent of 375. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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