Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
I.t.s. Gmbh
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. ...
Medical Devices·15,517 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article ...
Medical Devices·70 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: ...
Medical Devices·5,568 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 3...
Medical Devices·1,307 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Lockin...
Medical Devices·12,059 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved;...
Medical Devices·510 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1....
Medical Devices·46,637 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Lockin...
Medical Devices·176 affected·Jan 23, 2026
High RiskFDA
Datascope Corp.
CS300 IABP. Software Version CS300 IABP C.01.
Medical Devices·10,897 affected·Jan 23, 2026
High RiskFDA
Datascope Corp.
CS100 IABP. Software Version CS100 IABP Q.01.
Medical Devices·10,897 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular P...
Medical Devices·869 affected·Jan 23, 2026
High RiskFDA
I.t.s. Gmbh
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial...
Medical Devices·322 affected·Jan 23, 2026
High RiskFDA
Auris Health, Inc
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Medical Devices·173 affected·Jan 21, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK, Part No. 00055360004.
Medical Devices·51 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415005.
Medical Devices·8 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Model No. 00055430010.
Medical Devices·1,607 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430008.
Medical Devices·74 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415008.
Medical Devices·195 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407511.
Medical Devices·27 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360011.
Medical Devices·10 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407508.
Medical Devices·180 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445008.
Medical Devices·70 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407510.
Medical Devices·1,126 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360008.
Medical Devices·30 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445004.
Medical Devices·130 affected·Jan 20, 2026
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Medical Devices·4,885 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415010.
Medical Devices·1,629 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430004.
Medical Devices·253 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No: 00055415011.
Medical Devices·7 affected·Jan 20, 2026
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospe...
Medical Devices·49,367 affected·Jan 16, 2026
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound heal...
Medical Devices·2,906 affected·Jan 16, 2026
CriticalFDA
Olympus Corporation Of The Americas
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and sm...
Medical Devices·485 affected·Jan 16, 2026
CriticalFDA
Olympus Corporation Of The Americas
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and s...
Medical Devices·744 affected·Jan 16, 2026
High RiskFDA
Ge Healthcare
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Pro...
Medical Devices·250 affected·Jan 16, 2026
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINAT...
Medical Devices·55,276 affected·Jan 16, 2026
High RiskFDA
Aesculap Inc
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product...
Medical Devices·126 affected·Jan 15, 2026
High RiskFDA
Kob Gmbh
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Medical Devices·35,328 affected·Jan 15, 2026
High RiskFDA
Edermy Llc
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Medical Devices·11,202 affected·Jan 14, 2026
High RiskFDA
Medtronic Perfusion Systems
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Medical Devices·2 affected·Jan 13, 2026
High RiskFDA
Laerdal Medical Corporation
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA;...
Medical Devices·1,202 affected·Jan 13, 2026
High RiskFDA
Baxter Healthcare Corporation
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion...
Medical Devices·5 affected·Jan 13, 2026
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Medical Devices·2 affected·Jan 12, 2026
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Medical Devices·4 affected·Jan 12, 2026
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Medical Devices·44 affected·Jan 12, 2026
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Medical Devices·4 affected·Jan 12, 2026
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Medical Devices·3 affected·Jan 12, 2026
High RiskFDA
Medartis Ag
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable....
Medical Devices·0 affected·Jan 9, 2026
High RiskFDA
Fujifilm Healthcare Americas Corporation
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Medical Devices·16 affected·Jan 9, 2026