Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- 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 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 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 141 of 808
VITROS XT7600 Integrated System
Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Ortho-Clinical Diagnostics, Inc.
MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placem…
Avanos Medical, Inc.
X3 TRIATHLON CS INSERT NO 3 10 MM
Howmedica Osteonics Corp.
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
Synthes (USA) Products LLC
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Synthes (USA) Products LLC
VITROS XT 7600 Integrated System, Catalog No. 6844461
Ortho-Clinical Diagnostics, Inc.
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Paragon 28, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Ortho-Clinical Diagnostics, Inc.
Vantage Titan, Model: MRT-1504
Canon Medical System, USA, INC.
Synapse PACS - Version 7.3.000
FUJIFILM Healthcare Americas Corporation
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Paragon 28, Inc.
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Ortho-Clinical Diagnostics, Inc.
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embo…
Micro Therapeutics, Inc.
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Howmedica Osteonics Corp.
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Aesculap Inc
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone mar…
Synthes (USA) Products LLC
Synapse PACS - Version 7.2.200
FUJIFILM Healthcare Americas Corporation
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Ortho-Clinical Diagnostics, Inc.
X3 TRIATHLON CS INSERT NO 7 9 MM
Howmedica Osteonics Corp.
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Ortho-Clinical Diagnostics, Inc.
X3 TRIATHLON CS INSERT NO 6 11 MM
Howmedica Osteonics Corp.
DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
Aesculap Inc
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Howmedica Osteonics Corp.
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embo…
Micro Therapeutics, Inc.
Phantom TTC Nail, 10.0 X 200mm, Right
Paragon 28, Inc.
Embrace Drill Tower, Standard/Lateral (25mm)
Waldemar Link GmbH & Co. KG (Mfg Site)
TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
Synthes (USA) Products LLC
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Ortho-Clinical Diagnostics, Inc.
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Canon Medical System, USA, INC.
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Howmedica Osteonics Corp.
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Ortho-Clinical Diagnostics, Inc.
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defec…
Waldemar Link GmbH & Co. KG (Mfg Site)
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACER…
MEDLINE INDUSTRIES, LP - Northfield
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles o…
Integra LifeSciences Corp.
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c)…
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSC…
MEDLINE INDUSTRIES, LP - Northfield
Colonoscope, Model Number PCF-H190DL.
Olympus Corporation of the Americas
Colonoscope, Model Number CF-Q180AL.
Olympus Corporation of the Americas
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NU…
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, R…
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS137…
MEDLINE INDUSTRIES, LP - Northfield
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Vyaire Medical
Colonoscope, Model Number CF-H180AL.
Olympus Corporation of the Americas
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / Ident…
Alphatec Spine, Inc.
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
MEDLINE INDUSTRIES, LP - Northfield
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Vyaire Medical
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 Jul 2, 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 Jul 2, 2026.