Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,001–3,050 of 8,689
- Class II
Medical Device Recall · September 11, 2025
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6)The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- Class II
Medical Device Recall · September 11, 2025
TENACIO Pump with InhibiZone; UPN: 72404429;The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- Class II
Medical Device Recall · September 11, 2025
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneousThe failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
- Class II
Medical Device Recall · September 11, 2025
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, SizeDownstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
- Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Class II
Medical Device Recall · September 11, 2025
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80The devices were shipped unsterilized.
- Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-ACAdditional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Class I
Medical Device Recall · September 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheterAbbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Class I
Medical Device Recall · September 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheterAbbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Class II
Medical Device Recall · September 10, 2025
Medline Adult Anesthesia Set, REF DYNJ39985GSpecific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
- Class I
Medical Device Recall · September 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheterAbbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Class I
Medical Device Recall · September 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheterAbbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Class I
Medical Device Recall · September 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheterAbbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- Class I
Medical Device Recall · September 9, 2025
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 anesthetThe device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Class II
Medical Device Recall · September 9, 2025
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080The 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 9, 2025
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication SystemPotential that the measured value may be smaller than the actual area.
- Class I
Medical Device Recall · September 9, 2025
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 anesthetizThe device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Class II
Medical Device Recall · September 9, 2025
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 ENDOPotential 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 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 HPotential 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 I
Medical Device Recall · September 9, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-IThe unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
- Class II
Medical Device Recall · September 9, 2025
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 51Potential 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 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 CERAPotential 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 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 181Potential 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 I
Medical Device Recall · September 9, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-IFluctuations 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 II
Medical Device Recall · September 9, 2025
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEADPotential 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 8, 2025
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138Port 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 Clave Bag Spike w/ChemoLock Port REF: CL2150Port 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 Double ChemoLock Port Syringe Transfer Set REF: CL-33Port 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 Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188Port 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 ChemosafeLock Bag Spike REF: KL-BS001U3Port 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 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011Port 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 ChemoLock Bag Spike REF: CL-10Port 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 Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136Port 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
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 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950Port 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 ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5Port 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 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176Port 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 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118Port 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 ChemoLock Vial Spike, 20mm REF: CL-80SPort 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 Graduated Connector w/ChemoLock Port REF: CL3900Port 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 ChemoLock Port REF: CL2100Port 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 ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20Port 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 ChemoLock w/Mini Bag Spike ¿ REF: C-17Port 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 ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3Port 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 ChemoLock Port w/Spiros, Red Cap REF: CL-35Port 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 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951Port weld of drug transfer device may separate or break during use and potentially result in a leak.