FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 34 of 520
Moderate Apr 9, 2025
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Stryker Spine
Moderate Apr 9, 2025
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867…
GE Healthcare
Critical Apr 9, 2025
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathin…
Draeger, Inc.
Moderate Apr 9, 2025
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Stryker Corporation
Moderate Apr 9, 2025
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Reichert, Inc.
Moderate Apr 9, 2025
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Stryker Corporation
Moderate Apr 9, 2025
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Cordis US Corp
Moderate Apr 9, 2025
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Ethicon Endo Surgery, LLC
Moderate Apr 9, 2025
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Ethicon Endo Surgery, LLC
Critical Apr 9, 2025
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Pro…
Draeger, Inc.
Moderate Apr 9, 2025
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Stryker Corporation
Moderate Apr 9, 2025
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Stryker Corporation
Moderate Apr 9, 2025
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 203843…
GE Healthcare
Moderate Apr 9, 2025
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Stryker Corporation
Moderate Apr 9, 2025
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Reichert, Inc.
Moderate Apr 9, 2025
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
PYRAMES INC
Moderate Apr 9, 2025
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Stryker Corporation
Moderate Apr 9, 2025
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015;…
GE Healthcare
Moderate Apr 9, 2025
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
Stryker Corporation
Moderate Apr 9, 2025
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Stryker Corporation
Moderate Apr 9, 2025
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Stryker Spine
Moderate Apr 9, 2025
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics
Moderate Apr 9, 2025
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Terumo Cardiovascular Systems Corporation
Moderate Apr 9, 2025
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 203…
GE Healthcare
Moderate Apr 9, 2025
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Qiagen Sciences LLC
Moderate Apr 9, 2025
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 control v…
BD SWITZERLAND SARL
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product D…
American Contract Systems, Inc.
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Baxter Healthcare Corporation
Moderate Apr 2, 2025
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Baxter Healthcare Corporation
Moderate Apr 2, 2025
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 2…
Orthofix U.S. LLC
Moderate Apr 2, 2025
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -M…
St. Jude Medical
Moderate Apr 2, 2025
Baxter TruSystem 7500, Product Code 4091000
Baxter Healthcare Corporation
Moderate Apr 2, 2025
Baxter Stationary column TruSystem 7500, Product Code 1717020
Baxter Healthcare Corporation
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Merit Medical Systems, Inc.
Moderate Apr 2, 2025
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Baxter Healthcare Corporation
Moderate Apr 2, 2025
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Baxter Healthcare Corporation
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) D…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
American Contract Systems, Inc.
Moderate Apr 2, 2025
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack N…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
MEDLINE INDUSTRIES, LP - Northfield
Moderate Apr 2, 2025
namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
MEDLINE INDUSTRIES, LP - Northfield