Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 101 of 548
FDA Devices Critical Oct 18, 2023
2008T Hemodialysis SYS, with CDX
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Oct 18, 2023
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy…
RoyalVibe Health Ltd.
FDA Devices Moderate Oct 18, 2023
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Ansell Healthcare Products LLC
FDA Devices Moderate Oct 18, 2023
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surg…
Olympus Corporation of the Americas
FDA Devices Moderate Oct 18, 2023
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 18, 2023
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions…
Smiths Medical ASD Inc.
FDA Devices Critical Oct 18, 2023
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Fresenius Medical Care Holdings, Inc.
FDA Devices Critical Oct 18, 2023
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Oct 18, 2023
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0…
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 18, 2023
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMO…
Cardinal Health 200, LLC
FDA Devices Moderate Oct 18, 2023
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Preso…
Cardinal Health 200, LLC
FDA Devices Moderate Oct 18, 2023
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
TECHNO-PATH MANUFACTURING LTD.
FDA Devices Critical Oct 18, 2023
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Oct 18, 2023
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Beckman Coulter, Inc.
FDA Devices Moderate Oct 18, 2023
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 18, 2023
MED-810A Zemits NDPrime Laser products
Advance-Esthetic LLC
FDA Devices Moderate Oct 18, 2023
3T Heater Cooler System, REF: 16-02-85
LivaNova Deutschland GmbH
FDA Devices Moderate Oct 18, 2023
Access Thyroglobulin Calibrators
Beckman Coulter, Inc.
FDA Devices Moderate Oct 18, 2023
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate dep…
Flower Orthopedics Corporation
FDA Devices Moderate Oct 18, 2023
Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP2…
Cardinal Health 200, LLC
FDA Drug Moderate Oct 11, 2023
fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-200…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbroo…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Sui…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 9212…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 9212…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, …
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Sui…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-200…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Ce…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, …
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Roa…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, …
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbroo…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Dieg…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road,…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, …
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 9212…
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Oct 11, 2023
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C…
Central Admixture Pharmacy Services Inc
FDA Devices Moderate Oct 11, 2023
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
GE MEDICAL SYSTEMS, ISRAEL LTD.
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/…
Olympus Corporation of the Americas
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
Boston Scientific Corporation
FDA Devices Moderate Oct 11, 2023
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface o…
Apellis Pharmaceuticals, Inc.