FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 51 of 520
Moderate Nov 6, 2024
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including br…
Integra LifeSciences Corp.
Moderate Nov 6, 2024
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Remel, Inc
Moderate Nov 6, 2024
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Numb…
King Systems Corp. dba Ambu, Inc.
Moderate Nov 6, 2024
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
Integra LifeSciences Corp.
Moderate Nov 6, 2024
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including…
Integra LifeSciences Corp.
Moderate Nov 6, 2024
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number:…
King Systems Corp. dba Ambu, Inc.
Moderate Nov 6, 2024
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN…
Smith & Nephew Inc
Moderate Nov 6, 2024
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, m…
Smith & Nephew Inc
Moderate Nov 6, 2024
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Smith & Nephew Inc
Moderate Nov 6, 2024
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
Integra LifeSciences Corp.
Moderate Nov 6, 2024
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Olympus Corporation of the Americas
Moderate Nov 6, 2024
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, includin…
Integra LifeSciences Corp.
Moderate Oct 30, 2024
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B;…
MEDLINE INDUSTRIES, LP - Northfield
Critical Oct 30, 2024
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and a…
Datex-Ohmeda, Inc.
Moderate Oct 30, 2024
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
Baxter Healthcare Corporation
Moderate Oct 30, 2024
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK T…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
SynchroMed II Infusion Pump. Product Number: 8637-20
Medtronic Neuromodulation
Moderate Oct 30, 2024
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
medex Arterial Kit 1/EA, Product Code REF MX7827
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Smiths Medical ASD Inc.
Moderate Oct 30, 2024
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC24…
MEDLINE INDUSTRIES, LP - Northfield
Critical Oct 30, 2024
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used …
Datex-Ohmeda, Inc.
Moderate Oct 30, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
Baxter Healthcare Corporation
Moderate Oct 30, 2024
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Smiths Medical ASD Inc.
Moderate Oct 30, 2024
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent…
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Moderate Oct 30, 2024
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentar…
Olympus Corporation of the Americas
Moderate Oct 30, 2024
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM,…
Smiths Medical ASD Inc.
Critical Oct 30, 2024
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patient…
Datex-Ohmeda, Inc.
Moderate Oct 30, 2024
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Smiths Medical ASD Inc.
Critical Oct 30, 2024
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used on…
Datex-Ohmeda, Inc.
Moderate Oct 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Ad-Tech Medical Instrument Corporation
Moderate Oct 30, 2024
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Olympus Corporation of the Americas
Critical Oct 30, 2024
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only b…
Datex-Ohmeda, Inc.
Moderate Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Smiths Medical ASD Inc.
Moderate Oct 30, 2024
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Smiths Medical ASD, Inc.
Moderate Oct 30, 2024
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
Baxter Healthcare Corporation
Moderate Oct 30, 2024
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Smiths Medical ASD, Inc.
Critical Oct 30, 2024
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007…
Baxter Healthcare Corporation
Moderate Oct 30, 2024
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Smiths Medical ASD Inc.
Moderate Oct 30, 2024
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 30, 2024
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
MEDLINE INDUSTRIES, LP - Northfield