Open, ClassifiedPosted Dec 19, 2024·Initiated Nov 1, 2024
Exacta External Drainage and Monitoring System:
27581 KIT 27581 EXACTA W/EDM VCATH 35CM
27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK
27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN
27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP
27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ
27795 EDMS 27795 EXACTA 100ML CATH
27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL
46700 SYSTEM 46700 EXACTA DISP. DRAINAGE
46705 SYSTEM 46705 EXACTA DRAINAGE 100ML
The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).
Reason: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Root cause: Under Investigation by firm
Recalling firm: Medtronic NeurosurgeryType: Device, Monitoring, Intracranial PressureDistribution: Worldwide distribution. US nationwide including Puerto Rico; Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Bosnia And Herzegovina, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Honduras, Hong Kong, Iceland, Indonesia, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Lao People s Democratic Republic, Latvia, Lebanon, Libya, Malaysia, Malta, Mauritania, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Trinidad And Tobago, Tunisia, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.Recall #Z-0662-2025
Open, ClassifiedPosted Dec 19, 2024·Initiated Nov 19, 2024
Duravent Silicone Ventilation Tube. Model Number: 240075.
Reason: Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
Root cause: Process control
Recalling firm: Olympus Corporation of the AmericasType: Tube, TympanostomyDistribution: AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.Recall #Z-0707-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Oct 15, 2024
Brand Name: Atlan
Product Name: Atlan A300
Model/Catalog Number: 8211300
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Root cause: Process control
Recalling firm: Draeger Medical, Inc.Type: Gas-Machine, AnesthesiaDistribution: No Atlan A300 or A300XL devices were imported into the US.
Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries:
Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.Recall #Z-0667-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Oct 15, 2024
Brand Name: Atlan
Product Name: Atlan A300XL
Model/Catalog Number: 8621400
The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Root cause: Process control
Recalling firm: Draeger Medical, Inc.Type: Gas-Machine, AnesthesiaDistribution: No Atlan A300 or A300XL devices were imported into the US.
Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries:
Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.Recall #Z-0668-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 15, 2024
Brand Name: K-Systems
Product Name: G73 Dry Bath Incubator
Model/Catalog Number: K22065
Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.
Component: N/A
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
Root cause: Process change control
Recalling firm: CooperSurgical, Inc.Type: Accessory, Assisted Reproduction, ExemptDistribution: States: NC, NJ, TX, VA, IL, NY, CA, PA
Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines.
Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZARecall #Z-0687-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 15, 2024
Brand Name: K-Systems
Product Name: G85 Mini Incubator
Model/Catalog Number: K22074
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.
Component: No
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
Root cause: Process change control
Recalling firm: CooperSurgical, Inc.Type: Accessory, Assisted Reproduction, ExemptDistribution: States: NC, NJ, TX, VA, IL, NY, CA, PA
Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines.
Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZARecall #Z-0688-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 15, 2024
Brand Name: K-Systems
Product Name: T47 Warming Plate
Model/Catalog Number: K23054
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.
Component: No
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
Root cause: Process change control
Recalling firm: CooperSurgical, Inc.Type: Accessory, Assisted Reproduction, ExemptDistribution: States: NC, NJ, TX, VA, IL, NY, CA, PA
Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines.
Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZARecall #Z-0689-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 15, 2024
Brand Name: K-Systems
Product Name: T47 Warming Plate
Model/Catalog Number: K23055
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.
Component: No
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
Root cause: Process change control
Recalling firm: CooperSurgical, Inc.Type: Accessory, Assisted Reproduction, ExemptDistribution: States: NC, NJ, TX, VA, IL, NY, CA, PA
Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines.
Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZARecall #Z-0690-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 15, 2024
Brand Name: K-Systems
Product Name: R65 Trolley
Model/Catalog Number: K24012
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.
Component: N/A
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
Root cause: Process change control
Recalling firm: CooperSurgical, Inc.Type: Accessory, Assisted Reproduction, ExemptDistribution: States: NC, NJ, TX, VA, IL, NY, CA, PA
Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines.
Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZARecall #Z-0691-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 15, 2024
Brand Name: K-Systems
Product Name: Multiple/unknown
Model/Catalog Number: Multiple/unknown
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.
Component: N/A
Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
Root cause: Process change control
Recalling firm: CooperSurgical, Inc.Type: Accessory, Assisted Reproduction, ExemptDistribution: States: NC, NJ, TX, VA, IL, NY, CA, PA
Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines.
Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZARecall #Z-0692-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Oct 25, 2024
Galaxy System (GAL-001)
Reason: Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.
Root cause: Device Design
Recalling firm: Noah MedicalType: Bronchoscope (Flexible Or Rigid)Distribution: US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NYRecall #Z-0693-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 18, 2024
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Reason: Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Device, Fixation, Tracheal TubeDistribution: US and CanadaRecall #Z-0695-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 18, 2024
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Reason: Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Device, Fixation, Tracheal TubeDistribution: US and CanadaRecall #Z-0696-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 18, 2024
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
Reason: Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Device, Fixation, Tracheal TubeDistribution: US and CanadaRecall #Z-0697-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 18, 2024
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
Reason: Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Device, Fixation, Tracheal TubeDistribution: US and CanadaRecall #Z-0698-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Oct 29, 2024
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR;
EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL
Knee prosthesis component
Reason: Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
Root cause: Labeling Change Control
Recalling firm: MicroPort Orthopedics Inc.Type: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerDistribution: OUS: CN, GR, ES, ZA, FR, JP, ITRecall #Z-0699-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Dec 4, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) Model # WC71,
2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
Reason: Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: US and CanadaRecall #Z-0700-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Dec 4, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models:
1) Model # WC77,
2) Model # WC77D (Demo),
3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
Reason: Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: US and CanadaRecall #Z-0701-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Dec 4, 2024
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Reason: Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: US and CanadaRecall #Z-0702-2025
Open, ClassifiedPosted Dec 18, 2024·Initiated Nov 21, 2024
OEC 3D REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
Reason: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Root cause: Process control
Recalling firm: GE OEC Medical Systems, IncType: Image-Intensified Fluoroscopic X-Ray System, MobileDistribution: U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United KingdomRecall #Z-0703-2025