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 40 of 810
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly…
Theken Companies LLC
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUT…
Becton Dickinson & Co.
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
SEDECAL SA
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
SEDECAL SA
SM_40HF_B_D_VIR3.004, Mobile X-ray system
SEDECAL SA
Model Number 40KWFXPLUS.889, Mobile X-ray system
SEDECAL SA
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut …
ICU Medical, Inc.
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
SEDECAL SA
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA…
Synthes (USA) Products LLC
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
SEDECAL SA
SM_40HF_BDC, Mobile X-ray system
SEDECAL SA
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
RADPRO MOBILE, Mobile X-ray system
SEDECAL SA
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Cod…
GE Medical Systems, LLC
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 100043…
Abiomed, Inc.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray t…
Wipro GE Healthcare Private Ltd.
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter, Inc.
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UN…
Becton Dickinson & Co.
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
SEDECAL SA
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Model Number 40KWMOBILE3.899, Mobile X-ray system
SEDECAL SA
Model Number 40KWFXPLUS.005, Mobile X-ray system
SEDECAL SA
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
Cardinal Health 200, LLC
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
SEDECAL SA
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Pr…
B BRAUN MEDICAL INC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
UIH Technologies LLC
Model Number 40KWFXPLUS.002, Mobile X-ray system
SEDECAL SA
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
UIH Technologies LLC
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
SEDECAL SA
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the…
Becton Dickinson & Co.
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12F…
Cardinal Health 200, LLC
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
SEDECAL SA
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument To…
Becton Dickinson & Co.
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
SEDECAL SA
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
SEDECAL SA
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
SEDECAL SA
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
LeMaitre Vascular, Inc.
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
SEDECAL SA
SED URS LP, Mobile X-ray system
SEDECAL SA
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
UIH Technologies LLC
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.