FDA Device Recalls

Class IIIOngoing

Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1"X5YDS STR LF (12/CS) MGM61 Catalog #61-59320. d. DERMA SCIENCES, INC. MediHoney DRESSING, MEDIHONEY GEL STR TU0.5OZ (10/BX 4BX/CS) MGM61 Catalog #DUP31805. e. DERMA SCIENCES, INC DuPad PAD, ABD STR 8X10 (25/BX 8BX/CS) Catalog #DUP87810. f. DERMA SCIENCES, INC Shur-Conform Oil Emulsion non-adhering DRESSING, OIL EMULSION 3"X3"23251-210 DERSCI Catalog #DKC77041

Mckesson Medical-Surgical Inc. Corporate Office

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

May 25, 2022 · DeviceView details →

To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.

NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

GreenLight HPSEA Laser Fibers, UPN 0010-2092

SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.