Product category · Updated Aug 19, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.
- 41,070 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
41,070 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-28
Do more recalls mean more Class I danger?
Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 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 155 of 822
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 Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product
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 embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to incr
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 marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary ca
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 embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to incr
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 defects of the hip joint or proximal femur. Item Number: 184-280/12
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) LACERATION TRAY, REF DYNDL1484B;
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 of the brain.
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) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A
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 LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
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 NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRIC CULTURE PACK, REF DYNJ53966AH; g) HERNIA, REF CDS982034R; h) HERNIA, REF CDS982034S; i) HERNIA PACK, REF DYNJ39331B; j) LAP APPY PACK, REF DYNJ37709J; k) LAP CHOLE CDS, REF CDS983912V; l) LAP CHOLE CDS, REF
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, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
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 DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
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 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 232-10-85-300 / IdentiTi
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
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
MEDLINE INDUSTRIES, LP - Northfield
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 Aug 19, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.