Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,751–3,800 of 7,959
- Class II
Medical Device Recall · February 17, 2025
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;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
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;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 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
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Trial Tampon Box; Model Number: FG-TMP-REF04050504;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
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CONeonatal-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 17, 2025
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;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
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 FiltNeonatal-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 17, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 FilterNeonatal-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 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
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;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: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-PediatNeonatal-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 17, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2Neonatal-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 17, 2025
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;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 Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 SNeonatal-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 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
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;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: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989;Neonatal-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 17, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;Neonatal-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 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
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;Product lacks 510(k) clearance.
- Class II
Medical Device Recall · February 17, 2025
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;Product lacks 510(k) clearance.
- 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 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
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
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 = 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 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 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
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
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, 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 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.