Open, ClassifiedPosted Nov 7, 2025·Initiated Feb 2, 2023
BEAR Implant (Bridge-Enhanced ACL Restoration);
Model/Catalog: 1000;
Reason: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Root cause: Under Investigation by firm
Recalling firm: Miach OrthopaedicsType: Resorbable Implant For Anterior Cruciate Ligament (Acl) RepairDistribution: US Nationwide distribution.Recall #Z-0479-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 7, 2025
GM85 Digital Mobile X-ray imaging System;
Model Number: GM85;
Reason: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Root cause: Device Design
Recalling firm: NeuroLogica CorporationType: System, X-Ray, MobileDistribution: Domestic: US Nationwide Distribution.
International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungary, India, Italy, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab Emir., Vietnam,Recall #Z-0480-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 7, 2025
SimplyGo Mini, Standard Battery Kit;
Product code: 1116816;
The affected battery kits are sold as accessories for the SimplyGo Mini:
SimplyGo Mini Portable Oxygen Concentrator
Product code: 1113600
Reason: Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
Root cause: Nonconforming Material/Component
Recalling firm: Philips Respironics, Inc.Type: Generator, Oxygen, PortableDistribution: US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.Recall #Z-0481-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 6, 2025
Brand Name: Olympus Single Use Electrosurgical Snare SD-400
Product Name: Single Use Electrosurgical Snare
Model/Catalog Number: SD-400U-10
Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
Reason: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Root cause: Packaging
Recalling firm: Olympus Corporation of the AmericasType: Snare, FlexibleDistribution: Worldwide distribution - US Nationwide and the countries of GU, and MP.Recall #Z-0482-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 6, 2025
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400
Product Name: Single Use Single Use Electrosurgical Snare
Model/Catalog Number: SD-U400U-15
Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
Reason: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Root cause: Packaging
Recalling firm: Olympus Corporation of the AmericasType: Snare, FlexibleDistribution: Worldwide distribution - US Nationwide and the countries of GU, and MP.Recall #Z-0483-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Oct 23, 2025
BD Kiestra" Isolate Suspension Cuvette Array;
Catalog No.: 246100;
Reason: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Device, General Purpose, Microbiology, DiagnosticDistribution: Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.Recall #Z-0484-2026
Open, ClassifiedPosted Nov 7, 2025·Initiated Sep 25, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin);
CFN: SIGSDL45CTVT;
Reason: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Root cause: Process control
Recalling firm: Covidien, LPType: Staple, ImplantableDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.Recall #Z-0485-2026 Open, ClassifiedPosted Nov 7, 2025·Initiated Sep 25, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin);
BOX LOBECTOMIA VATS 3D;
CFN: BOX06170V4;
Reason: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Root cause: Process control
Recalling firm: Covidien, LPType: Staple, ImplantableDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.Recall #Z-0486-2026 Open, ClassifiedPosted Nov 6, 2025·Initiated Oct 9, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Root cause: Device Design
Recalling firm: B-K Medical A/SType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.Recall #Z-0435-2026
Open, ClassifiedPosted Nov 6, 2025·Initiated Oct 9, 2025
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Root cause: Device Design
Recalling firm: B-K Medical A/SType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.Recall #Z-0436-2026
Open, ClassifiedPosted Nov 6, 2025·Initiated Oct 9, 2025
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Root cause: Device Design
Recalling firm: B-K Medical A/SType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.Recall #Z-0437-2026
Open, ClassifiedPosted Nov 6, 2025·Initiated Oct 9, 2025
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Root cause: Device Design
Recalling firm: B-K Medical A/SType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.Recall #Z-0438-2026
Open, ClassifiedPosted Nov 6, 2025·Initiated Oct 9, 2025
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Root cause: Device Design
Recalling firm: B-K Medical A/SType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.Recall #Z-0439-2026
Open, ClassifiedPosted Nov 6, 2025·Initiated Oct 9, 2025
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Root cause: Device Design
Recalling firm: B-K Medical A/SType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.Recall #Z-0440-2026
Open, ClassifiedPosted Nov 6, 2025·Initiated Sep 17, 2025
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Reason: Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.
Root cause: Nonconforming Material/Component
Recalling firm: Beckman Coulter Inc.Type: System, Test, Low Density, LipoproteinDistribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA, HI, IA, ID, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, PR, QC, SC, TX, WA, WV and the country of Canada.Recall #Z-0441-2026
Open, ClassifiedPosted Nov 5, 2025·Initiated Aug 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers
T1-C and T1-CS.
Reason: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted:
Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: OSSTEM Implant Co., Ltd.Type: X-Ray, Tomography, Computed, DentalDistribution: U.S.Recall #Z-0313-2026
Open, ClassifiedPosted Nov 5, 2025·Initiated Aug 26, 2025
Osstem Dental X-Ray System T2. Product Model Numbers
T2-C and T2-CS.
Reason: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted:
Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: OSSTEM Implant Co., Ltd.Type: X-Ray, Tomography, Computed, DentalDistribution: U.S.Recall #Z-0314-2026
Open, ClassifiedPosted Nov 5, 2025·Initiated Aug 26, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers
T2-C-P and T2-CS-P.
Reason: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted:
Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: OSSTEM Implant Co., Ltd.Type: X-Ray, Tomography, Computed, DentalDistribution: U.S.Recall #Z-0315-2026
Open, ClassifiedPosted Nov 5, 2025·Initiated Oct 6, 2025
Tandem Mobi Insulin Pump:
Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
Pump, Tandem Mobi, Control-IQ/1010750,
Pump, Tandem Mobi, Control-IQ, Replacement/1012719,
Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501,
Pump, Tandem Mobi, Control-IQ 7.7/1013655,
Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656,
Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700,
Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081
Reason: Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.
Root cause: Software design
Recalling firm: Tandem Diabetes Care, Inc.Type: Alternate Controller Enabled Insulin Infusion PumpDistribution: US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, PT, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WYRecall #Z-0427-2026
Open, ClassifiedPosted Nov 5, 2025·Initiated Sep 23, 2025
Brand Name: Klassic BiPolar Head
Model/Catalog Number:
3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head;
3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head;
3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head;
3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head;
3205.45.028 Klassic BiPolar Head, 45 mm OD, 28 mm Head;
3205.46.028 Klassic BiPolar Head, 46 mm OD, 28 mm Head;
3205.47.028 Klassic BiPolar Head, 47 mm OD, 28 mm Head;
3205.48.028 Klassic BiPolar Head, 48 mm OD, 28 mm Head;
3205.49.028 Klassic BiPolar Head, 49 mm OD, 28 mm Head;
3205.50.028 Klassic BiPolar Head, 50 mm OD, 28 mm Head;
3205.51.028 Klassic BiPolar Head, 51 mm OD, 28 mm Head;
3205.52.028 Klassic BiPolar Head, 52 mm OD, 28 mm Head;
3205.53.028 Klassic BiPolar Head, 53 mm OD, 28 mm Head;
3205.54.028 Klassic BiPolar Head, 54 mm OD, 28 mm Head;
3205.55.028 Klassic BiPolar Head, 55 mm OD, 28 mm Head;
3205.56.028 Klassic BiPolar Head, 56 mm OD, 28 mm Head;
3205.58.028 Klassic BiPolar Head, 58 mm OD, 28 mm Head;
3205.60.028 Klassic BiPolar Head, 60 mm OD, 28 mm Head
Reason: 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.
Root cause: Packaging
Recalling firm: Total Joint Orthopedics, Inc.Type: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedDistribution: US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.Recall #Z-0432-2026