Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH G...
Medical Devices·270,311 affected·Feb 27, 2026
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: T...
Medical Devices·408 affected·Feb 27, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Medical Devices·270,311 affected·Feb 27, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ832...
Medical Devices·270,311 affected·Feb 27, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HE...
Medical Devices·270,311 affected·Feb 27, 2026
CriticalFDA
Medline Industries, Lp
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medl...
Medical Devices·1,752,096 affected·Feb 27, 2026
CriticalFDA
Medline Industries, Lp
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as fo...
Medical Devices·60 affected·Feb 27, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Medical Devices·270,311 affected·Feb 27, 2026
CriticalFDA
Medline Industries, Lp
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as fo...
Medical Devices·20 affected·Feb 27, 2026
CriticalFDA
Medline Industries, Lp
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as fo...
Medical Devices·1,698 affected·Feb 27, 2026
High RiskFDA
Medline Industries, Lp
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number...
Medical Devices·74,085 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model ...
Medical Devices·3,183 affected·Feb 25, 2026
High RiskFDA
Synthes (usa) Products Llc
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Medical Devices·77 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
Medical Devices·89 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VAS...
Medical Devices·513 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
Medical Devices·24,170 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
Medical Devices·36 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
Medical Devices·1,720 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF...
Medical Devices·58,836 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
Medical Devices·75 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
Medical Devices·27 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTR...
Medical Devices·2,609 affected·Feb 25, 2026
High RiskFDA
Medline Industries, Lp
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJ...
Medical Devices·38,230 affected·Feb 25, 2026
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Medical Devices·21,291 affected·Feb 23, 2026
High RiskFDA
Amo Puerto Rico Manufacturing, Inc.
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery...
Medical Devices·361 affected·Feb 19, 2026
High RiskFDA
Xtant Medical Holdings, Inc
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Medical Devices·2 affected·Feb 18, 2026
High RiskFDA
Mentor Texas, Lp.
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, Hig...
Medical Devices·0 affected·Feb 18, 2026
High RiskFDA
Mentor Texas, Lp.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height ...
Medical Devices·0 affected·Feb 18, 2026
High RiskFDA
Elekta, Inc.
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ ...
Medical Devices·352 affected·Feb 18, 2026
High RiskFDA
Mentor Texas, Lp.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Styl...
Medical Devices·0 affected·Feb 18, 2026
CriticalFDA
Abiomed, Inc.
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and correspo...
Medical Devices·33,107 affected·Feb 18, 2026
High RiskFDA
Mentor Texas, Lp.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Medical Devices·0 affected·Feb 18, 2026
High RiskFDA
Mentor Texas, Lp.
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High ...
Medical Devices·0 affected·Feb 18, 2026
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Cub Pediatric Crib, Model FL19H
Medical Devices·590 affected·Feb 18, 2026
CriticalFDA
Navajo Manufacturing Company
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Medical Devices·28,457 affected·Feb 18, 2026
High RiskFDA
Mentor Texas, Lp.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156...
Medical Devices·0 affected·Feb 18, 2026
High RiskFDA
Mentor Texas, Lp.
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profil...
Medical Devices·0 affected·Feb 18, 2026
High RiskFDA
Molded Products Inc
See Luer Cap Set, MPC-130, set, administration, intravascular
Medical Devices·26,900 affected·Feb 17, 2026
High RiskFDA
Medline Industries, Lp
THORACIC ROBOTS, DYNJ908777B
Medical Devices·14,379 affected·Feb 16, 2026
High RiskFDA
Medline Industries, Lp
Airway Exam Kit, DYKE1796
Medical Devices·14,379 affected·Feb 16, 2026
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; P...
Medical Devices·62 affected·Feb 16, 2026
High RiskFDA
Medline Industries, Lp
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYK...
Medical Devices·14,379 affected·Feb 16, 2026
High RiskFDA
Medline Industries, Lp
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BR...
Medical Devices·14,379 affected·Feb 16, 2026
High RiskFDA
Convatec, Inc
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Medical Devices·0 affected·Feb 16, 2026
High RiskFDA
Convatec, Inc
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Medical Devices·0 affected·Feb 16, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Medical Devices·9,040 affected·Feb 13, 2026
CriticalFDA
Merit Medical Systems, Inc.
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Medical Devices·368,264 affected·Feb 13, 2026
High RiskFDA
Medline Industries, Lp
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Medical Devices·651,789 affected·Feb 13, 2026