FDA Device · 2025
FDA Device recalls in 2025
RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.
- stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixe…
FDA Device · Class II · 2025-04-16 · Tornier S - MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
FDA Device · Class II · 2025-04-16 · Medline Industries Northfield - DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qua…
FDA Device · Class II · 2025-04-16 · Beckman Coulter - GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015
FDA Device · Class II · 2025-04-09 · Ge Healthcare - Phoroptor VRx Digital Refraction System Model Numbers: 16242
FDA Device · Class II · 2025-04-09 · Reichert - Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
FDA Device · Class II · 2025-04-09 · Stryker - Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
FDA Device · Class II · 2025-04-09 · Stryker - BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are con…
FDA Device · Class II · 2025-04-09 · Bd Switzerland Sarl - Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
FDA Device · Class II · 2025-04-09 · Cordis Us - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not appli…
FDA Device · Class I · 2025-04-09 · Draeger - Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
FDA Device · Class II · 2025-04-09 · Stryker - GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001
FDA Device · Class II · 2025-04-09 · Ge Healthcare - Monterey AL Implant Inserter
FDA Device · Class II · 2025-04-09 · Stryker Spine - Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
FDA Device · Class II · 2025-04-09 · Qiagen Sciences - Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
FDA Device · Class II · 2025-04-09 · Stryker - Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
FDA Device · Class II · 2025-04-09 · Stryker - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applic…
FDA Device · Class I · 2025-04-09 · Draeger - ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
FDA Device · Class II · 2025-04-09 · Ethicon Endo Surgery - Phoroptor VRx Digital Refraction System Model Numbers: 16241
FDA Device · Class II · 2025-04-09 · Reichert - GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001
FDA Device · Class II · 2025-04-09 · Ge Healthcare - PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
FDA Device · Class II · 2025-04-09 · Ethicon Endo Surgery - Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
FDA Device · Class II · 2025-04-09 · Stryker - GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001
FDA Device · Class II · 2025-04-09 · Ge Healthcare - Pacific Hemostasis Thromboplastin-D, 4 ml
FDA Device · Class II · 2025-04-09 · Fisher Diagnostics - DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC…
FDA Device · Class II · 2025-04-09 · Beckman Coulter - Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
FDA Device · Class II · 2025-04-09 · Stryker - A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System
FDA Device · Class II · 2025-04-09 · Medtronic Neuromodulation - Monterey AL Implant Inserter
FDA Device · Class II · 2025-04-09 · Stryker Spine - Pacific Hemostasis Thromboplastin-D, 10 ml
FDA Device · Class II · 2025-04-09 · Fisher Diagnostics - Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
FDA Device · Class II · 2025-04-09 · Stryker - Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Device · Class II · 2025-04-09 · Terumo Cardiovascular Systems - Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
FDA Device · Class II · 2025-04-09 · Stryker - Boppli: Bedside Device Kit, REF: 54-0002
FDA Device · Class II · 2025-04-09 · Pyrames - Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
FDA Device · Class II · 2025-04-09 · Cordis Us - Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Br…
FDA Device · Class I · 2025-04-09 · Draeger - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicab…
FDA Device · Class I · 2025-04-09 · Draeger - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicab…
FDA Device · Class I · 2025-04-09 · Draeger - Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicab…
FDA Device · Class I · 2025-04-09 · Draeger - Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
FDA Device · Class II · 2025-04-09 · Stryker - Monterey AL Implant Inserter
FDA Device · Class II · 2025-04-09 · Stryker Spine - Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
FDA Device · Class II · 2025-04-09 · Stryker - PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
FDA Device · Class II · 2025-04-09 · Ethicon Endo Surgery - Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
FDA Device · Class II · 2025-04-09 · Stryker - Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
FDA Device · Class II · 2025-04-09 · Stryker - Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
FDA Device · Class II · 2025-04-09 · Stryker - Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description…
FDA Device · Class I · 2025-04-09 · Draeger - GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077
FDA Device · Class II · 2025-04-09 · Ge Healthcare - PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
FDA Device · Class II · 2025-04-09 · Ethicon Endo Surgery - Monterey AL Implant Inserter
FDA Device · Class II · 2025-04-09 · Stryker Spine - Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Brand Name: Banner University Med Ctr
FDA Device · Class II · 2025-04-02 · American Contract Systems - namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description:…
FDA Device · Class II · 2025-04-02 · American Contract Systems - namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control mater…
FDA Device · Class II · 2025-04-02 · Microbiologics - Baxter Stationary column TruSystem 7500, Product Code 1717020
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33m…
FDA Device · Class II · 2025-04-02 · Orthofix U S - Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018
FDA Device · Class I · 2025-04-02 · Calyxo - Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Baxter Mobile column TruSystem 7500 U, Product Code 1730720
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Baxter TruSystem 7500, Product Code 4091000
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Baxter Stationary column TruSystem 7500 U, Product Code 1730731
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF…
FDA Device · Class II · 2025-04-02 · Checkpoint Surgical - Baxter Floor mounting column TS 7500 U, Product Code 1730732
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
FDA Device · Class II · 2025-04-02 · Zimmer - Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
FDA Device · Class II · 2025-04-02 · American Contract Systems - Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Premier Solo Diamond - Large Invented Cone
FDA Device · Class II · 2025-04-02 · Premier Dental Products - Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 40193…
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Ast…
FDA Device · Class II · 2025-04-02 · Coopervision - Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
FDA Device · Class II · 2025-04-02 · Merit Medical Systems - Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF#…
FDA Device · Class II · 2025-04-02 · Checkpoint Surgical - Baxter Floor mounting column TruSystem 7500, Product Code 1717021
FDA Device · Class II · 2025-04-02 · Baxter Healthcare
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)