Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

1251–1275 of 13399

HighFDA (Devices)·Z-0971-2026·2025-12-31
Orthopedic nail implants recalled due to potential fatigue fracture risk
Zimmer is recalling Affixus Antegrade Femoral Nailing System implants that may have undersized distal diameter, creating risk of implant fatigue fracture and potential need for surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0969-2026·2025-12-31
Affixus Antegrade Femoral Nailing System Recalled for Implant Fracture Risk
Zimmer is recalling specific lots of Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fracture. Affected patients may experience tissue damage or adverse reactions requiring additional surgery.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2026·2025-12-31
Affixus Antegrade Femoral Nails: Potential fatigue fracture due to undersized distal diameter
Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails due to potential undersized distal diameter that could cause implant fatigue fracture. No injuries have been reported.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2026·2025-12-31
AGFA DR 800 X-Ray System Radiation Dose Limit Bypass Risk
AGFA Healthcare is recalling the DR 800 digital radiography system because it can exceed safe radiation dose limits if the frame rate is increased while the ABS safety feature is disabled. Nationwide distribution affects 35 units.
Product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2026·2025-12-31
Rosch-Uchida Transjugular Liver Access Sets recalled for manufacturing defects
Cook Incorporated is recalling 23 units of Rosch-Uchida Transjugular Liver Access Sets due to manufacturing specification defects. Devices may have been cut to incorrect lengths, improperly trimmed, or inadequately inspected.
Product
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0976-2026·2025-12-31
Femoral Nails Recalled for Risk of Implant Fatigue Fracture
Zimmer, Inc. is recalling Affixus Antegrade Femoral Nails due to undersized distal diameters that could cause implant fatigue fracture. The defect may lead to non-union, malunion, or tissue damage requiring surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2026·2025-12-31
Zimmer Affixus Femoral Nails Recalled for Fatigue Fracture Risk
Zimmer Affixus Antegrade Femoral Nails may develop undersized defects leading to implant fatigue fracture, potentially causing pain, tissue damage, and the need for revision surgery. The FDA Class II recall affects 11 units distributed nationwide.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0991-2026·2025-12-31
Diasol Dialysis Concentrate Recalled Due to Safety and Efficacy Concerns
Diasol, Inc. is recalling a dialysis concentrate product because safety and efficacy cannot be assured. The recall affects 74,400 gallons distributed in six US states.
Product
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2026·2025-12-31
Femoral Nailing System Implants Recalled for Undersized Distal Diameter Risk
Zimmer's Affixus femoral nails may have undersized distal diameters risking implant fracture. Affected patients may experience pain, failed bone healing, or require additional surgery.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2026·2025-12-31
Zimmer Affixus Femoral Nails Recalled for Potential Fatigue Fracture Risk
Zimmer, Inc. is recalling 22 Affixus Antegrade Femoral Nailing systems due to an undersized distal diameter defect that could cause implant fatigue fracture. Potential complications include tissue damage and surgical intervention may be required.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2026·2025-12-31
Cook Ring Transjugular Intrahepatic Access Sets Recalled for Manufacturing Defects
Cook Incorporated is recalling 15 units of Ring Transjugular Intrahepatic Access Sets due to manufacturing defects. Affected devices may have been cut to incorrect length, improperly trimmed, and inadequately inspected.
Product
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0997-2026·2025-12-31
Beckman Coulter Bicarbonate Reagent Recall Due to False Test Results
Beckman Coulter Bicarbonate reagent may produce falsely high test results due to interference with lactate dehydrogenase (LDH) in the sample. Approximately 36,981 units have been distributed worldwide, with 35,320 in the United States.
Product
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2026·2025-12-31
Diasol Dialysis Concentrate Recalled for Safety and Efficacy Assurance Issues
Diasol Inc. is recalling a dialysis concentrate product because safety and efficacy cannot be assured. The product is distributed nationwide in Missouri, California, Arizona, Texas, Illinois, and Massachusetts.
Product
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0993-2026·2025-12-31
Flexor Check-Flo Introducers and Sets Recalled for Manufacturing Defects
Cook Medical is recalling Flexor Check-Flo Introducers and Sets due to manufacturing defects. Affected products may have been cut to incorrect lengths, improperly trimmed, or inadequately inspected.
Product
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) K
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0966-2026·2025-12-31
LifeShield Infusion Software Recalled for Concentration Limit Precision Defect
LifeShield Drug Library Management software limits drug concentration precision to one decimal place instead of three, potentially forcing users to deviate from manufacturer recommendations and risking medication delivery errors.
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2026·2025-12-31
Affixus Femoral Nails Recalled for Potential Implant Fatigue Fracture
Zimmer, Inc. is recalling Affixus Antegrade Femoral Nailing System implants with undersized distal diameter that could fracture during use, potentially requiring surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2026·2025-12-31
Affixus Antegrade Femoral Nails Recalled for Undersized Distal Diameter
Zimmer is recalling limited units of Affixus Antegrade Femoral Nails due to undersized distal diameter that may cause implant fracture. Potential complications include non-union, malunion, and tissue damage requiring surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2026·2025-12-31
Diasol Dialysis Concentrate Recalled for Safety and Efficacy Concerns
Diasol, Inc. is recalling 186,000 containers of dialysis concentrate because the manufacturer cannot assure product safety and efficacy. The recall affects dialysis centers in six states.
Product
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2026·2025-12-31
Zimmer Affixus Femoral Nails Recalled for Undersized Components
Zimmer is recalling 22 Affixus Antegrade Femoral Nails due to undersized distal diameters that may cause implant fracture and complications including pain and tissue damage requiring surgery.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2026·2025-12-31
Zimmer Affixus Femoral Nails Risk of Fatigue Fracture
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fatigue fracture. Affected patients may experience pain, non-union, tissue damage, and may require surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2026·2025-12-31
Automated Dispensing Cabinet Firmware Update Causes Drawer Malfunction
A firmware update to BD Pyxis automated medication dispensing cabinets causes drawer failure, potentially delaying access to critical hospital medications.
Product
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2026·2025-12-31
Affixus Femoral Nails recalled for undersized shaft fracture risk
Zimmer is recalling Affixus Antegrade Femoral Nails (Model 815509420) due to undersized shaft diameter that may cause implant fracture, potentially requiring additional surgery.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2026·2025-12-31
Diasol dialysis concentrate: safety and efficacy cannot be assured
Diasol, Inc. is recalling its Diasol liquid concentrate for bicarbonate dialysis because the safety and efficacy of the product cannot be assured. The recall affects 7,200 gallons distributed nationwide.
Product
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2026·2025-12-31
Zimmer Affixus Antegrade Femoral Nails Recalled for Fatigue Fracture Risk
Zimmer is recalling 24 units of Affixus Antegrade Femoral Nails due to a manufacturing defect that could cause implant fracture. Patients who received these units should contact their healthcare provider.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2026·2025-12-31
Laboratory Reference Material May Fail to Provide Target Organism
Microbiologics Inc is recalling KWIK-STIK 6-Pack Campylobacter jejuni reference material because affected units may fail to recover the target organism needed for quality control testing.
Product
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Category
Medical Device
Distribution
Distributed nationwide

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