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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 4741–4760 of 39,430 recalls

Class IIOngoing

MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869; 6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035; 7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040; 8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O; 9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C; 10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B; 11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C; 12) CONTINUOUS EPIDURAL, REF PAIN1271A; 13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B; 14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317; 15) 20G CONT. EPID TRAY, REF PAIN1353B; 16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358; 17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361; 18) JHAC CONT EPIDURAL, REF PAIN1437A; 19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B; 20) EPIDURAL CATH KIT, REF PAIN1536A; 21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547; 22) EPIDURAL TRAY, REF PAIN1558; 23) CONTINUOUS EPIDURAL, REF PAIN1581A; 24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A; 25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B; 26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A; 27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636; 28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A; 29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A; 30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709; 31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A; 32) CONTINUOUS EPIDURAL, REF PAIN1766A; 33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806; 34) EPIDURAL TRAY IMF 103130, REF PAIN1807; 35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816; 36) CONTINUOUS EPIDURAL, REF PAIN1844; 37) CSE TRAY, REF PAIN1845; 38) BWH L&D EPIDURAL KIT, REF PAIN1846; 39) 17G CONT. EPI - MRI SAFE, REF PAIN1854; 40) 17G L&D CONT. EPIDURAL, REF PAIN1855; 41) CONTINUOUS/CSE TRAY, REF PAIN1856; 42) CONTINUOUS/CSE TRAY, REF PAIN1856A; 43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864; 44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A; 45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878; 46) CSE TRAY, REF PAIN1885; 47) TEAM HEALTH EPIDURAL, REF PAIN1887; 48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888; 49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890; 50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892; 51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893; 52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894; 53) CSE TRAY, REF PAIN1898; 54) CSE TRAY, REF PAIN1904; 55) 17/25G CSE TRAY, REF PAIN1919; 56) CSE TRAY, REF PAIN1920; 57) 17/25G CSE TRAY, REF PAIN1937; 58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940; 59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958; 60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967; 61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014; 62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025; 63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026; 64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028; 65) 17G CONT EPIDURAL NYLON, REF PAIN9030; 66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031; 67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034; 68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035; 69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036; 70) REINIF 19G EPI CATH S STERILE, REF REPICATH19; 71) CONT. EPIDURAL TRAY, REF SAMPA0105; 72) EPIDURAL CATH PACK, REF SAMPA0106; 73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110; 74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111

MEDLINE INDUSTRIES, LP - Northfield

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

October 16, 2024 · DeviceView details →

Class IIOngoing

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

CORNEAT VISION, LTD.

Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.

October 16, 2024 · DeviceView details →

Class IIOngoing

MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644

MEDLINE INDUSTRIES, LP - Northfield

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

October 16, 2024 · DeviceView details →

Class IIOngoing

MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A

MEDLINE INDUSTRIES, LP - Northfield

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

October 16, 2024 · DeviceView details →

Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 16, 2024 · DeviceView details →

Class IIOngoing

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

IDS LTD

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

October 16, 2024 · DeviceView details →

Class IIOngoing

MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A

MEDLINE INDUSTRIES, LP - Northfield

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

October 16, 2024 · DeviceView details →

Class IIOngoing

MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector

MEDLINE INDUSTRIES, LP - Northfield

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

October 16, 2024 · DeviceView details →

Class IIOngoing

Acrobat-i Positioner. Model Number C-XP-5000Z

Maquet Cardiovascular, LLC

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

October 16, 2024 · DeviceView details →

Class IIOngoing

Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.

Smith & Nephew, Inc.

The Bipolar assembly contains an oversized Retainer Ring.

October 15, 2024 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.

Draeger Medical, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

October 15, 2024 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

Draeger Medical, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

October 15, 2024 · DeviceView details →

Class IIOngoing

(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.

MEDLINE INDUSTRIES, LP - Northfield

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

October 15, 2024 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

Draeger Medical, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

October 15, 2024 · DeviceView details →

Class IIOngoing

(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.

MEDLINE INDUSTRIES, LP - Northfield

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

October 15, 2024 · DeviceView details →

Class IIOngoing

Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.

MEDLINE INDUSTRIES, LP - Northfield

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

October 15, 2024 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.

Draeger Medical, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

October 15, 2024 · DeviceView details →

Class IIIOngoing

a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

Alcon Research LLC

Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

October 15, 2024 · DeviceView details →

Class IIOngoing

OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.

OrganOx Ltd

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

October 15, 2024 · DeviceView details →

Class IIOngoing

Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)

Defibtech, LLC

Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

October 14, 2024 · DeviceView details →

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