Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 2,101–2,150 of 7,959

Medical Device Recall · September 30, 2025
Medline Industries, LP
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Class II
Medical Device Recall · September 30, 2025
IMPRIS Imaging Inc
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
Medical Device Recall · September 30, 2025
Medline Industries, LP
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Class II
Medical Device Recall · September 30, 2025
Prismatik Dentalcraft, Inc.
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
Incorrect titanium screw, packaged with dental implant.
Class II
Medical Device Recall · September 30, 2025
Medline Industries, LP
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Class II
Medical Device Recall · September 30, 2025
Medline Industries, LP
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Class II
Medical Device Recall · September 30, 2025
Medline Industries, LP
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Class II
Medical Device Recall · September 30, 2025
CareFusion 303, Inc.
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class II
Medical Device Recall · September 30, 2025
SHENZHEN ATOMSTACK TECHNOLOGIES
Material Processing Laser Products
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Class II
Medical Device Recall · September 30, 2025
Medline Industries, LP
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Class II
Medical Device Recall · September 30, 2025
IMPRIS Imaging Inc
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Class I
Medical Device Recall · September 29, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blo
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
DSAART LLC
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Ca
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Bl
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a c
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
Medistim Asa
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound
Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
Integra LifeSciences Corp. (NeuroSciences)
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Class I
Medical Device Recall · September 26, 2025
DSAART LLC
Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
GE Healthcare Finland Oy
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms R
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a c
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
DSAART LLC
Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Class II
Medical Device Recall · September 26, 2025
DSAART LLC
Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
Integra LifeSciences Corp. (NeuroSciences)
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Class I
Medical Device Recall · September 26, 2025
Synthes (USA) Products LLC
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
GE Healthcare Finland Oy
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Class II
Medical Device Recall · September 26, 2025
GE Healthcare Finland Oy
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
DSAART LLC
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code:
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Class II
Medical Device Recall · September 26, 2025
Zimmer, Inc.
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Class II
Medical Device Recall · September 26, 2025
DSAART LLC
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 righ
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II
Medical Device Recall · September 26, 2025
GE Healthcare Finland Oy
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Class II
Medical Device Recall · September 26, 2025
Synthes (USA) Products LLC
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Class II
Medical Device Recall · September 26, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube c
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II