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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 421–440 of 1,000 recalls

Class IIOngoing

Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

Siemens Healthcare Diagnostics, Inc.

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

July 13, 2026 · DeviceView details →

Class IIOngoing

Blanketrol II Model 222S; Thermal regulating system.

Gentherm Medical, LLC

Overheating of the 115V CPU board may cause the device to shut down.

July 13, 2026 · DeviceView details →

Class IIOngoing

Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Siemens Healthcare Diagnostics, Inc.

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

July 13, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: " Total Knee Arthroplasty " Unicompartmental Knee Arthroplasty: Tibial Transverse Resection " Hip Arthroplasty The ARVIS" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information. Component: NA

Kico Knee Innovation Company

Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

July 13, 2026 · DeviceView details →

Class IIOngoing

Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respiratory gas humidifier.

Medline Industries, LP

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

July 13, 2026 · DeviceView details →

Class IIOngoing

MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

Medtronic MiniMed, Inc.

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

July 13, 2026 · DeviceView details →

Class IIOngoing

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

Siemens Healthcare Diagnostics Products Ltd.

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

July 13, 2026 · DeviceView details →

Class IIOngoing

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Siemens Healthcare Diagnostics Products Ltd.

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

July 13, 2026 · DeviceView details →

Class IIOngoing

MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;

Medtronic MiniMed, Inc.

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

July 13, 2026 · DeviceView details →

Class IIOngoing

Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT); 3) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT); 4) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT); 5) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT); 6) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL HTD, DUAL LIMB,COLUMN, Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT); 7) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD SINGLE LIMB,INFANT, Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT); 8) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD,INFANT,HTD,COLUMN,DRN, Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT); 9) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT); 10) MEDLINE HUDSON RCI,ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT); 11) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT).

Medline Industries, LP

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

July 13, 2026 · DeviceView details →

Class IIOngoing

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

Medtronic MiniMed, Inc.

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

July 13, 2026 · DeviceView details →

Class IIOngoing

Blanketrol III, Model 233; Thermal regulating system.

Gentherm Medical, LLC

Overheating of the 115V CPU board may cause the device to shut down.

July 13, 2026 · DeviceView details →

Class IIOngoing

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Straumann USA LLC

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

July 13, 2026 · DeviceView details →

Class IIOngoing

Innercool Coolblue Console, Model STx; Thermal regulating system.

Gentherm Medical, LLC

Overheating of the 115V CPU board may cause the device to shut down.

July 13, 2026 · DeviceView details →

Class IIOngoing

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

OBP Medical Corporation

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

July 13, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

AVID Medical, Inc.

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

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