Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 4,101–4,150 of 7,959
- Class II
Medical Device Recall · December 23, 2024
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Class II
Medical Device Recall · December 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
- Class II
Medical Device Recall · December 23, 2024
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
- Class II
Medical Device Recall · December 23, 2024
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Class II
Medical Device Recall · December 23, 2024
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Class I
Medical Device Recall · December 23, 2024
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLEDue to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
- Class II
Medical Device Recall · December 23, 2024
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Class II
Medical Device Recall · December 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
- Class II
Medical Device Recall · December 23, 2024
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated forSnap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class I
Medical Device Recall · December 20, 2024
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
- Class II
Medical Device Recall · December 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- Class II
Medical Device Recall · December 20, 2024
Baxter Solution Set with Duo-Vent Spike, REF 2R8404Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class I
Medical Device Recall · December 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002APThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft maDue to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
- Class I
Medical Device Recall · December 20, 2024
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
Medical Device Recall · December 20, 2024
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic anSutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class I
Medical Device Recall · December 20, 2024
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
- Class I
Medical Device Recall · December 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class I
Medical Device Recall · December 20, 2024
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002APThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthaSutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in USSutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 19, 2024
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,LONG TIP FORCEPS,IS4000 REF 471048Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,MEGA SUTURECUT ND,IS4000 REF 471309Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,PROGRASP FORCEPS,IS4000 REF 471093Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CEScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
Jinan Bodor Cnc Machine Co Ltd
Bodor P and C series laser cutting machinesNon-compliant laser products
- Class II
Medical Device Recall · December 19, 2024
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,FORCE BIPOLAR,IS4000 REF 470405Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.