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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 1601–1620 of 39,430 recalls

Class IIOngoing

Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Cook Incorporated

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

November 26, 2025 · DeviceView details →
Class IIOngoing

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit SKU DYNDV1691B; 5) OUTPATIENT 2 TO 5 YEARS, Medline kit SKU DYNDV2464A.

Medline Industries, LP

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

November 26, 2025 · DeviceView details →
Class IIOngoing

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B

Medline Industries, LP

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

November 26, 2025 · DeviceView details →
Class IIOngoing

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.

Medline Industries, LP

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

November 26, 2025 · DeviceView details →
Class IIOngoing

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.

Medline Industries, LP

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

November 26, 2025 · DeviceView details →
Class IOngoing

MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4

Medline Industries, LP

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

November 26, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No

Ferndale Laboratories, Inc.

Butyrate tube cracks during actuation, rendering product unusable.

November 25, 2025 · DeviceView details →
Class IIOngoing

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Smith & Nephew, Inc.

Removal of affected lot of screws due to labeling error.

November 24, 2025 · DeviceView details →
Class IIOngoing

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

ICU Medical, Inc.

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

November 24, 2025 · DeviceView details →
Class IIOngoing

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

Zimmer Surgical Inc

The devices may have a misaligned thickness control bar.

November 24, 2025 · DeviceView details →
Class IOngoing

Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

Draeger, Inc.

A certain component of affected devices was not delivered within specification and contained impurities.

November 24, 2025 · DeviceView details →
Class IIOngoing

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

ICU Medical, Inc.

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

November 24, 2025 · DeviceView details →
Class IOngoing

FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Abbott Diabetes Care, Inc.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

November 24, 2025 · DeviceView details →
Class IIOngoing

Zimmer Dermatome AN, Model/Catalog Number: 88710100

Zimmer Surgical Inc

The devices may have a misaligned thickness control bar.

November 24, 2025 · DeviceView details →
Class IOngoing

FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Abbott Diabetes Care, Inc.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

November 24, 2025 · DeviceView details →
Class IOngoing

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

Alcon Research LLC

Ophthalmic procedure packs may have incomplete seals affecting sterility.

November 24, 2025 · DeviceView details →
Class IOngoing

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

Draeger, Inc.

A certain component of affected devices was not delivered within specification and contained impurities.

November 24, 2025 · DeviceView details →
Class IOngoing

FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Abbott Diabetes Care, Inc.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

November 24, 2025 · DeviceView details →
Class IOngoing

FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Abbott Diabetes Care, Inc.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

November 24, 2025 · DeviceView details →
Class IIOngoing

Male Fertility Sperm Test for Home Use (Cassette)

Changchun Wancheng Bio-Electron Co., Ltd.

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

November 22, 2025 · DeviceView details →
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