Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,501–4,550 of 8,689
- Class II
Medical Device Recall · February 17, 2025
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.Increased risk for valve housing detachment causing leakage.
- Class II
Medical Device Recall · February 17, 2025
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric IntubatedNeonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
- Class II
Medical Device Recall · February 15, 2025
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantatiDue to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
- Class II
Medical Device Recall · February 14, 2025
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
- Class II
Medical Device Recall · February 14, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Class II
Medical Device Recall · February 14, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Class II
Medical Device Recall · February 14, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Class II
Medical Device Recall · February 14, 2025
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
- Class I
Medical Device Recall · February 13, 2025
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24The 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 ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Class II
Medical Device Recall · February 13, 2025
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 (1The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Class I
Medical Device Recall · February 13, 2025
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Class II
Medical Device Recall · February 13, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product DThe 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
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AThe 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 MINOR PACK and LAPAROSCOPY. Sterile surgical drape.Potential breach in pouch packaging which could lead to loss of sterility.
- Class II
Medical Device Recall · February 13, 2025
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 tThe potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Class I
Medical Device Recall · February 13, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24The 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 ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 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 I
Medical Device Recall · February 13, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Class II
Medical Device Recall · February 13, 2025
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 tThe 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
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 extThe potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Class I
Medical Device Recall · February 13, 2025
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24The 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 ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Class II
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; DRAPPotential breach in pouch packaging which could lead to loss of sterility.
- Class II
Medical Device Recall · February 13, 2025
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic useProduct 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 I
Medical Device Recall · February 13, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Class II
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
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
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
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 (AThe potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Class I
Medical Device Recall · February 13, 2025
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 21-4173-24The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 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
MEDLINE INDUSTRIES, LP - Northfield
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.Potential breach in pouch packaging which could lead to loss of sterility.
- Class I
Medical Device Recall · February 13, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24The 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
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127Affected 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 II
Medical Device Recall · February 13, 2025
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic useProduct 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
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-8The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
- Class I
Medical Device Recall · February 13, 2025
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 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 kitThe 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 600605710The 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, Super MobileThe 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
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.