Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 3,801–3,850 of 7,959

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAP

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated ext

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for t

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as FACE LIFT. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for t

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  Remel, Inc

  remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

  Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

  Class II

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (1

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127

  Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

  Class I

• Medical Device Recall · February 13, 2025

  Smiths Medical ASD, Inc.

  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

  The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

  Class I

• Medical Device Recall · February 13, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

  Class II

• Medical Device Recall · February 13, 2025

  ZOLL Medical Corporation

  Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (A

  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

  Class II

• Medical Device Recall · February 12, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323;

  The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

  Class II

• Medical Device Recall · February 12, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710

  The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

  Class II

• Medical Device Recall · February 12, 2025

  Becton Dickinson & Co.

  BD BBL TB Stain Kit K, Catalog (REF): 212522

  One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.

  Class II

• Medical Device Recall · February 12, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160

  The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

  Class II

• Medical Device Recall · February 12, 2025

  MITO RED LIGHT INC

  Mito Red Light, Super Mobile

  The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

  Class II

• Medical Device Recall · February 12, 2025

  Zimmer, Inc.

  Z1 Femoral Hip System, Product Number 611777612

  There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

  Class II

• Medical Device Recall · February 12, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

  The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

  Class II

• Medical Device Recall · February 12, 2025

  Remel, Inc

  Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

  Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pa

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DA

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  FUJIFILM Healthcare Americas Corporation

  Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

  The incorrect computed patient age is showing in VX for patients less than 3 months old.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pac

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DY

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCO

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DE

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYN

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pa

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · February 11, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGR

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

  Class II