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Baxter Healthcare Corporation

250 FDA 510(k) clearances · Recalling firm

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◉ Watch Baxter Healthcare Corporation

RecordFirmDate
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Adm recall (Z-2766-2026)Baxter Healthcare Corporation2026-08-11
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF recall (Z-2548-2026)Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number RE recall (Z-2549-2026)Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number recall (Z-2550-2026)Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Numbe recall (Z-2551-2026)Baxter Healthcare Corporation2026-07-01
Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with recall (Z-2638-2026)Baxter Healthcare Corporation2026-07-01
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H9381 recall (Z-2262-2026)Baxter Healthcare Corporation2026-05-29
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory recall (Z-1637-2026)Baxter Healthcare Corporation2026-04-01
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/C recall (Z-1573-2026)Baxter Healthcare Corporation2026-03-18
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software recall (Z-1368-2026)Baxter Healthcare Corporation2026-02-13
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 recall (Z-1121-2026)Baxter Healthcare Corporation2026-01-16
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement recall (Z-0847-2026)Baxter Healthcare Corporation2025-12-01
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Pr recall (Z-0233-2026)Baxter Healthcare Corporation2025-10-23
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve recall (Z-0189-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-i recall (Z-0190-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/m recall (Z-0191-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves recall (Z-0192-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valv recall (Z-0193-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valv recall (Z-0194-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Lu recall (Z-0195-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK recall (Z-0196-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer recall (Z-0197-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer recall (Z-0198-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer recall (Z-0199-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 recall (Z-0200-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves recall (Z-0201-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valv recall (Z-0202-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK L recall (Z-0203-2026)Baxter Healthcare Corporation2025-10-16
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519 recall (Z-0204-2026)Baxter Healthcare Corporation2025-10-16
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck recall (Z-2594-2025)Baxter Healthcare Corporation2025-09-19
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump recall (Z-2332-2025)Baxter Healthcare Corporation2025-08-29
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump recall (Z-2333-2025)Baxter Healthcare Corporation2025-08-29
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump recall (Z-2334-2025)Baxter Healthcare Corporation2025-08-29
Spectrum IQ Infusion Pump, Product Code 3570009 recall (Z-2415-2025)Baxter Healthcare Corporation2025-08-22
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS recall (Z-2173-2025)Baxter Healthcare Corporation2025-08-14
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX recall (Z-2095-2025)Baxter Healthcare Corporation2025-07-17
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 recall (Z-2096-2025)Baxter Healthcare Corporation2025-07-17
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient recall (Z-2031-2025)Baxter Healthcare Corporation2025-07-09
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits fo recall (Z-2032-2025)Baxter Healthcare Corporation2025-07-09
Baxter Novum IQ Syringe Pump, product code 40800BAXUS, recall (Z-1964-2025)Baxter Healthcare Corporation2025-06-12
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Prod recall (Z-1962-2025)Baxter Healthcare Corporation2025-06-11
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100 recall (Z-1816-2025)Baxter Healthcare Corporation2025-05-23
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS recall (Z-1767-2025)Baxter Healthcare Corporation2025-05-20
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) recall (Z-1725-2025)Baxter Healthcare Corporation2025-05-09
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-00 recall (Z-1726-2025)Baxter Healthcare Corporation2025-05-09
Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84M recall (Z-1562-2025)Baxter Healthcare Corporation2025-04-15
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74C recall (Z-1563-2025)Baxter Healthcare Corporation2025-04-15
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part recall (Z-1564-2025)Baxter Healthcare Corporation2025-04-15
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; recall (Z-1565-2025)Baxter Healthcare Corporation2025-04-15
Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77 recall (Z-1566-2025)Baxter Healthcare Corporation2025-04-15
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1 recall (Z-1567-2025)Baxter Healthcare Corporation2025-04-15
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece R recall (Z-1568-2025)Baxter Healthcare Corporation2025-04-15
Welch Allyn Connex Vital Signs Monitor (CVSM): recall (Z-1558-2025)Baxter Healthcare Corporation2025-04-14
Welch Allyn CONNEX Accessory Power Management Stand: recall (Z-1559-2025)Baxter Healthcare Corporation2025-04-14
Welch Allyn CP150 Electrocardiograph: recall (Z-1560-2025)Baxter Healthcare Corporation2025-04-14
Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complic recall (Z-1468-2025)Baxter Healthcare Corporation2025-03-26
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 recall (Z-1409-2025)Baxter Healthcare Corporation2025-03-21
Baxter Stationary column TruSystem 7500, Product Code 1717020 recall (Z-1410-2025)Baxter Healthcare Corporation2025-03-21
Baxter Floor mounting column TruSystem 7500, Product Code 1717021 recall (Z-1411-2025)Baxter Healthcare Corporation2025-03-21
Baxter Mobile column TruSystem 7500, Product Code 1717023 recall (Z-1412-2025)Baxter Healthcare Corporation2025-03-21
Baxter Mobile column TruSystem 7500 U, Product Code 1730720 recall (Z-1413-2025)Baxter Healthcare Corporation2025-03-21
Baxter Stationary column TruSystem 7500 U, Product Code 1730731 recall (Z-1414-2025)Baxter Healthcare Corporation2025-03-21
Baxter Floor mounting column TS 7500 U, Product Code 1730732 recall (Z-1415-2025)Baxter Healthcare Corporation2025-03-21
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 recall (Z-1416-2025)Baxter Healthcare Corporation2025-03-21
Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 recall (Z-1417-2025)Baxter Healthcare Corporation2025-03-21
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 recall (Z-1418-2025)Baxter Healthcare Corporation2025-03-21
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 recall (Z-1419-2025)Baxter Healthcare Corporation2025-03-21
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 recall (Z-1420-2025)Baxter Healthcare Corporation2025-03-21
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 recall (Z-1421-2025)Baxter Healthcare Corporation2025-03-21
Baxter TruSystem 7500, Product Code 4091000 recall (Z-1422-2025)Baxter Healthcare Corporation2025-03-21
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS recall (Z-1423-2025)Baxter Healthcare Corporation2025-03-21
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX recall (Z-1253-2025)Baxter Healthcare Corporation2025-03-06
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 recall (Z-1254-2025)Baxter Healthcare Corporation2025-03-06
Baxter Solution Set with Duo-Vent Spike, REF 2R8404 recall (Z-1009-2025)Baxter Healthcare Corporation2025-01-22
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 recall (Z-1010-2025)Baxter Healthcare Corporation2025-01-22
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 recall (Z-1011-2025)Baxter Healthcare Corporation2025-01-22
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 recall (Z-0884-2025)Baxter Healthcare Corporation2025-01-16
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A recall (Z-0885-2025)Baxter Healthcare Corporation2025-01-16
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP recall (Z-0886-2025)Baxter Healthcare Corporation2025-01-16
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP recall (Z-0887-2025)Baxter Healthcare Corporation2025-01-16
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 357 recall (Z-0775-2025)Baxter Healthcare Corporation2024-12-27
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 357 recall (Z-0776-2025)Baxter Healthcare Corporation2024-12-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in recall (Z-0559-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use i recall (Z-0560-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in recall (Z-0561-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in recall (Z-0562-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in recall (Z-0563-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use i recall (Z-0564-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in recall (Z-0565-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in recall (Z-0566-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in recall (Z-0567-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C43 recall (Z-0568-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4 recall (Z-0569-2025)Baxter Healthcare Corporation2024-11-27
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in recall (Z-0373-2025)Baxter Healthcare Corporation2024-11-20
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use i recall (Z-0374-2025)Baxter Healthcare Corporation2024-11-20
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in recall (Z-0375-2025)Baxter Healthcare Corporation2024-11-20
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in recall (Z-0376-2025)Baxter Healthcare Corporation2024-11-20
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in recall (Z-0377-2025)Baxter Healthcare Corporation2024-11-20
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use i recall (Z-0378-2025)Baxter Healthcare Corporation2024-11-20
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in recall (Z-0379-2025)Baxter Healthcare Corporation2024-11-20
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Every clearance here is in the API, with alerts when new ones post.