Medical Device Recalls

7,979 medical device recalls from federal enforcement feeds.

Showing 7,401–7,450 of 7,979

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE

  Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

  Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777

  Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

  Class I

• Medical Device Recall · December 28, 2023

  MRP, LLC dba Aquabiliti

  AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syrin

  The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.

  Class II

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T

  Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE

  The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777

  Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777

  Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T

  Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

  Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

  The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

  Class I

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE

  The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

  Class I

• Medical Device Recall · December 28, 2023

  Maquet Medical Systems USA

  Bubble Sensor (REF: 70105.5720)

  The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

  Class II

• Medical Device Recall · December 28, 2023

  NeuroLogica Corporation

  Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

  Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.

  Class II

• Medical Device Recall · December 28, 2023

  Cardinal Health 200, LLC

  Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE

  The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

  Class I

• Medical Device Recall · December 27, 2023

  TruAbutment Inc.

  Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A

  Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

  Class II

• Medical Device Recall · December 27, 2023

  Abiomed, Inc.

  Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005

  New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

  Class II

• Medical Device Recall · December 27, 2023

  Abiomed, Inc.

  Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Cod

  IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

  Class I

• Medical Device Recall · December 26, 2023

  Wipro GE Healthcare Private Ltd.

  GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850

  GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

  Class I

• Medical Device Recall · December 26, 2023

  Wipro GE Healthcare Private Ltd.

  GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814

  GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

  Class I

• Medical Device Recall · December 26, 2023

  Wipro GE Healthcare Private Ltd.

  GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

  GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

  Class I

• Medical Device Recall · December 26, 2023

  Wipro GE Healthcare Private Ltd.

  GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500

  GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

  Class I

• Medical Device Recall · December 26, 2023

  Wipro GE Healthcare Private Ltd.

  GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

  GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

  Class I

• Medical Device Recall · December 26, 2023

  GE Medical Systems, SCS

  Senographe Pristina

  X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

  Class II

• Medical Device Recall · December 26, 2023

  Ossur H / F

  Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

  Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.

  Class II

• Medical Device Recall · December 26, 2023

  Wipro GE Healthcare Private Ltd.

  GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822

  GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

  Class I

• Medical Device Recall · December 22, 2023

  Musculoskeletal Transplant Foundation, Inc.

  AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

  Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

  Class II

• Medical Device Recall · December 22, 2023

  Windstone Medical Packaging, Inc.

  Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

  Sterility assurance for saline included in surgical kits cannot be guaranteed.

  Class I

• Medical Device Recall · December 22, 2023

  Baxter Healthcare Corporation

  Baxter Exactamix Pro 2400, REF EXM24DY

  An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

  Class I

• Medical Device Recall · December 22, 2023

  Onkos Surgical, Inc.

  ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

  Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

  Class II

• Medical Device Recall · December 22, 2023

  Musculoskeletal Transplant Foundation, Inc.

  AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)

  Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

  Class II

• Medical Device Recall · December 22, 2023

  Onkos Surgical, Inc.

  ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

  Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

  Class II

• Medical Device Recall · December 22, 2023

  Baxter Healthcare Corporation

  Baxter Exactamix Pro 1200, REF EXM12DY

  An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

  Class I

• Medical Device Recall · December 22, 2023

  Howmedica Osteonics Corp.

  HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty

  Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

  Class II

• Medical Device Recall · December 22, 2023

  GE HEALTHCARE AUSTRIA GMBH & CO

  GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis

  GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.

  Class II

• Medical Device Recall · December 22, 2023

  Windstone Medical Packaging, Inc.

  Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO

  Sterility assurance for saline included in surgical kits cannot be guaranteed.

  Class I

• Medical Device Recall · December 22, 2023

  Howmedica Osteonics Corp.

  HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty

  Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

  Class II

• Medical Device Recall · December 22, 2023

  Windstone Medical Packaging, Inc.

  Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO

  Sterility assurance for saline included in surgical kits cannot be guaranteed.

  Class I

• Medical Device Recall · December 22, 2023

  Windstone Medical Packaging, Inc.

  Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

  Sterility assurance for saline included in surgical kits cannot be guaranteed.

  Class I

• Medical Device Recall · December 21, 2023

  AMD Medicom Inc.

  HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

  Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

  Class II

• Medical Device Recall · December 21, 2023

  Covidien LP

  Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-

  Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

  Class II

• Medical Device Recall · December 21, 2023

  MICROVENTION INC.

  TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

  Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

  Class II

• Medical Device Recall · December 21, 2023

  AMD Medicom Inc.

  HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)

  Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

  Class II

• Medical Device Recall · December 21, 2023

  Cardinal Health 200, LLC

  Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516

  The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

  Class II

• Medical Device Recall · December 21, 2023

  Paragon 28, Inc.

  Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L

  Medical devices distributed, prior to sterilization

  Class II

• Medical Device Recall · December 21, 2023

  Cardinal Health 200, LLC

  CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

  The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.

  Class II

• Medical Device Recall · December 21, 2023

  Paragon 28, Inc.

  Phantom TTC Nail, 10.0 X 200mm, Right

  Medical devices distributed, prior to sterilization

  Class II

• Medical Device Recall · December 21, 2023

  AMD Medicom Inc.

  PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)

  Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

  Class II

• Medical Device Recall · December 21, 2023

  MEDLINE INDUSTRIES, LP - Northfield

  MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A

  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.

  Class II

• Medical Device Recall · December 21, 2023

  MEDLINE INDUSTRIES, LP - Northfield

  MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B

  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.

  Class II