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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 381–400 of 1,000 recalls

Class IIOngoing

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

Olympus Corporation of the Americas

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus Corporation of the Americas

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus Corporation of the Americas

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

February 25, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Olympus Corporation of the Americas

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

Olympus Corporation of the Americas

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

February 25, 2026 · DeviceView details →
Class IIOngoing

Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B

Medline Industries, LP

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

February 25, 2026 · DeviceView details →
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