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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 3681–3700 of 39,430 recalls

Class IIOngoing

Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

INSTITUT GEORGES LOPEZ

The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

March 13, 2025 · DeviceView details →
Class IOngoing

HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.

Thoratec LLC

Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.

March 13, 2025 · DeviceView details →
Class IOngoing

Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable

Draeger, Inc.

The potential for cracks forming in the breathing circuit hose.

March 12, 2025 · DeviceView details →
Class IOngoing

Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

Conavi Medical Inc.

Due to manufacturing issues there is a potential for the catheter sheath to detach.

March 12, 2025 · DeviceView details →
Class IOngoing

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

Draeger, Inc.

The potential for cracks forming in the breathing circuit hose.

March 12, 2025 · DeviceView details →
Class IIOngoing

Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

Qiagen Sciences LLC

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

March 12, 2025 · DeviceView details →
Class IOngoing

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only

Draeger, Inc.

The potential for cracks forming in the breathing circuit hose.

March 12, 2025 · DeviceView details →
Class IOngoing

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only

Draeger, Inc.

The potential for cracks forming in the breathing circuit hose.

March 12, 2025 · DeviceView details →
Class IOngoing

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

Draeger, Inc.

The potential for cracks forming in the breathing circuit hose.

March 12, 2025 · DeviceView details →
Class IOngoing

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

Draeger, Inc.

The potential for cracks forming in the breathing circuit hose.

March 12, 2025 · DeviceView details →
Class IOngoing

Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable

Draeger, Inc.

The potential for cracks forming in the breathing circuit hose.

March 12, 2025 · DeviceView details →
Class IIOngoing

BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.

CareFusion 303, Inc.

Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.

March 11, 2025 · DeviceView details →
Class IIOngoing

Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

Siemens Healthcare Diagnostics, Inc.

Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

March 11, 2025 · DeviceView details →
Class IIOngoing

BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 155144-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 155145-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 155157-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P / 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 155153-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 155155-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 155147-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 155149-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 155150-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 169-114 BD PYXIS MEDBANK MINI CR-4HH-P / 169-115 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 169-83 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 169-85 BD PYXIS MEDBANK TWR MN CR-14HH-P / 169-86 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 169-89 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 169-91 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /169-93 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 169-95 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 169-99 BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 138913-01 BD PYXIS MEDBANK MINI CR-4HH-P / 138911-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P / 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P / 139002-01 BD PYXIS MEDBANK MN 200 CR-4HH-P / 139000-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P / 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P / 139018-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P / 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P / 139021-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P / 139022-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 138975-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 138976-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 138977-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 139085-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 138964-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 138965-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 138970-01 BD Pyxis QFill Replenishment Station / 138904-01 KIT BD PYXIS QFILL REPLENISHMENT STATION / 155197-01 MEDBANK UPOS211 AIO WIN10 QFILL 1.5 / 155215-05 OPT,MEDBANK,HD,WIN10,QFILL,CR / 131944-04 The BD Pyxis" MedBank" CUBIE" Replenishment Station is an Automated Dispensing Cabinet (ADC) that is intended to be used by a qualified and authorized user to replenish medications and supplies to a BD Pyxis" MedBank" cabinet.

CareFusion 303, Inc.

Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.

March 11, 2025 · DeviceView details →
Class IOngoing

BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784

Bard Access Systems, Inc.

Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

March 11, 2025 · DeviceView details →
Class IIOngoing

BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI 2HH-1FM, 138906-01; MINI 3HH-1FG, 169-110; MINI 3HH-1FG, 139091-01; MINI 3HH-1HM, 169-111; MINI 4HH, 138910-01; MINI 4HH, 169-112; MINI 4HM, 169-113; MINI 4HM, 138915-01; TWR MN 10HH-1FH-1FM, 169-23; TWR MN 10HH-2FH, 169-24; TWR MN 10HH-2FH, 138955-01; TWR MN 10HH-2FM, 169-25; TWR MN 10HH-2FM, 138924-01; TWR MN 12HH-1FF, 169-26; TWR MN 12HH-1FF, 138960-01; TWR MN 12HH-1FH, 169-27; TWR MN 12HH-1FH, 138961-01; TWR MN 12HH-1FM, 169-28; TWR MN 12HH-1FM, 138926-01; TWR MN 14HH, 138927-01; TWR MN 14HH, 169-29; TWR MN 1HH-1HM-2FM-4FF, 169-30; TWR MN 2FH-2HM-4FM, 169-31; TWR MN 2HH-10HM-1FM, 169-32; TWR MN 2HH-1FH-5FM, 169-33; TWR MN 2HH-2FH-4FM, 169-34; TWR MN 2HH-4FH-2FM, 169-139; TWR MN 2HH-4HM-4FM, 139125-01; TWR MN 2HH-6FM, 169-38; TWR MN 2HH-6FM, 138919-01; TWR MN 2HH-6HM-3FM, 169-39; TWR MN 2HH-8HM-2FM, 169-40; TWR MN 2HM-6FM, 169-41; TWR MN 3FH-4FM, 169-42; TWR MN 3FH-4FM, 138933-01; TWR MN 3FH-8HH MEDPASS, 169-140; TWR MN 3HH-7HM-2FM, 169-43; TWR MN 4HH-10HM, 169-44; TWR MN 4HH-10HM, 138959-01; TWR MN 4HH-1FH-2HM-3FM, 169-45; TWR MN 4HH-1FH-4FM, 169-46; TWR MN 4HH-1FH-4HM-2FM, 169-47; TWR MN 4HH-2FH-2HM-2FM, 169-49; TWR MN 4HH-2FH-3FM, 169-50; TWR MN 4HH-2FH-3FM, 138931-01; TWR MN 4HH-3FH-2FM, 169-52; TWR MN 4HH-4FH-1FM, 169-53; TWR MN 4HH-4FH-1FM, 138940-01; TWR MN 4HH-4HM-3FM, 169-54; TWR MN 4HH-4HM-3FM, 138952-01; TWR MN 4HH-5FH, 169-55; TWR MN 4HH-5FM, 169-56; TWR MN 4HH-5FM, 138918-01; TWR MN 4HH-6HM-2FM, 169-57; TWR MN 4HM-5FM, 169-59; TWR MN 5HH-3HM-3FM, 169-60; TWR MN 5HH-9HM, 138914-01; TWR MN 5HH-9HM, 169-61; TWR MN 6FH-1FM, 169-62; TWR MN 6HH-1FH-2HM-2FM, 169-63; TWR MN 6HH-1FH-3FM, 169-64; TWR MN 6HH-2FH-2FM, 169-65; TWR MN 6HH-4FH, 169-67; TWR MN 6HH-4FH, 138957-01; TWR MN 6HH-4FM, 169-68; TWR MN 6HH-4FM, 138922-01; TWR MN 6HH-4HM-2FM, 169-69; TWR MN 6HH-8HM, 169-71; TWR MN 6HH-8HM, 138958-01; TWR MN 7FH, 169-72; TWR MN 7FH, 138920-01; TWR MN 7FM, 169-73; TWR MN 7FM, 138937-01; TWR MN 7HH-1HM-3FM, 139086-01; TWR MN 7HH-1HM-3FM, 169-74; TWR MN 8HH-1FH-2FM, 169-75; TWR MN 8HH-2FH-1FM, 169-77; TWR MN 8HH-2HM-2FM, 169-78; TWR MN 8HH-2HM-2FM, 138939-01; TWR MN 8HH-3FF, 169-79; TWR MN 8HH-3FH, 169-80; TWR MN 8HH-3FH, 138956-01; TWR MN 8HH-3FM, 169-81; TWR MN 8HH-3FM, 138923-01. BD PYXIS MEDFLEX MN (Name, REF): 1000 12HH, 139055-01; 1000 2HH-2FM, 139041-01; 1000 2HH-5FM, 139046-01; 1000 4HH-4FM, 139049-01; 1000 6HH-3FM, 139051-01; 1000 8HH-2FM, 139052-01; 2000 8HH-2FH, 139165-01; 2000 8HH-2FM, 139069-01. MEDBANK MAIN, 1137-00; MEDBANK MINI MAIN, 1147-00; MEDBANK TOWER MAIN, 1145-00; MEDFLEX, 1119-00; MEDFLEX 2.0, 1139-00

CareFusion 303, Inc.

Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

March 11, 2025 · DeviceView details →
Class IIOngoing

Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

Philips North America Llc

Potential for collimator to fall as a result of incorrect installation.

March 10, 2025 · DeviceView details →
Class IIOngoing

Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).

Maquet Cardiovascular, LLC

Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.

March 10, 2025 · DeviceView details →
Class IIOngoing

Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

Philips North America Llc

Potential for collimator to fall as a result of incorrect installation.

March 10, 2025 · DeviceView details →
Class IIOngoing

NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164

Medtronic Xomed, Inc.

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

March 10, 2025 · DeviceView details →
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