Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 2,301–2,350 of 7,959

• Medical Device Recall · September 9, 2025

  Draeger, Inc.

  Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetiz

  The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

  Class I

• Medical Device Recall · September 9, 2025

  BioPro, Inc.

  BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERA

  Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

  Class II

• Medical Device Recall · September 9, 2025

  BioPro, Inc.

  BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO

  Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

  Class II

• Medical Device Recall · September 9, 2025

  BioPro, Inc.

  BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 H

  Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

  Class II

• Medical Device Recall · September 9, 2025

  Draeger, Inc.

  Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthet

  The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

  Class I

• Medical Device Recall · September 9, 2025

  BioPro, Inc.

  BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51

  Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

  Class II

• Medical Device Recall · September 9, 2025

  NOXBOX LTD

  NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

  Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

  Class I

• Medical Device Recall · September 9, 2025

  BioPro, Inc.

  BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 181

  Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

  Class II

• Medical Device Recall · September 9, 2025

  Biomet, Inc.

  Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

  The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemosafeLock Connecter REF: KL-FNU3

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  Beckman Coulter, Inc.

  CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

  Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ChemoLock Bag Spike, 01 units REF: CL-10-10

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Port REF: CL2100

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  Beckman Coulter, Inc.

  MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo

  Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Bag Spike REF: CL-10

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical ChemoLock Closed Vial Spike REF: CL-80

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 8, 2025

  ICU Medical, Inc.

  ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

  Port weld of drug transfer device may separate or break during use and potentially result in a leak.

  Class II

• Medical Device Recall · September 6, 2025

  Iantrek Inc.

  Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-i

  Potential for compromised integrity of the sterile packaging.

  Class II