Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 recalls
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 69 of 810
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Siemens Healthcare Diagnostics, Inc.
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitati…
Beckman Coulter, Inc.
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-…
CareFusion 303, Inc.
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah…
Qapel Medical Inc.
stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality …
Tornier S.A.S.
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog N…
Tornier S.A.S.
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, T…
MEDLINE INDUSTRIES, LP - Northfield
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Tornier S.A.S.
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D …
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
MEDLINE INDUSTRIES, LP - Northfield
Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCO…
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
MEDLINE INDUSTRIES, LP - Northfield
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnat…
Agilent Technologies, Inc.
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEW…
MEDLINE INDUSTRIES, LP - Northfield
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number M…
Tornier S.A.S.
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Stryker Corporation
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Stryker Corporation
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Stryker Corporation
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Stryker Corporation
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Stryker Spine
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867…
GE Healthcare
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathin…
Draeger, Inc.
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Stryker Corporation
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Reichert, Inc.
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Stryker Corporation
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Cordis US Corp
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Ethicon Endo Surgery, LLC
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Ethicon Endo Surgery, LLC
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Pro…
Draeger, Inc.
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Stryker Corporation
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Stryker Corporation
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 203843…
GE Healthcare
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Stryker Corporation
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Reichert, Inc.
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
PYRAMES INC
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Stryker Corporation
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
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
Stryker Corporation
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Stryker Corporation
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Stryker Spine
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Terumo Cardiovascular Systems Corporation
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 203…
GE Healthcare
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
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
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable P…
Draeger, Inc.
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Medtronic Neuromodulation
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026…
GE Healthcare
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Stryker Corporation
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices — browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA — openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls
- Source: NHTSA — National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jun 3, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jun 3, 2026.