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 · 2026-10-03
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 245 of 822
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Aesculap Implant Systems LLC
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
Baxter Healthcare Corporation
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Surgical Innovations Ltd
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Aesculap Implant Systems LLC
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
Baxter Healthcare Corporation
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Siemens Medical Solutions USA, Inc
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Aesculap Implant Systems LLC
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, REF: SFP914190. Used in the placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or
Stryker Neurovascular
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Becton Dickinson & Company
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Randox Laboratories Ltd.
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Aesculap Implant Systems LLC
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Aesculap Implant Systems LLC
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Aesculap Implant Systems LLC
Aqualung Recalls i330R SCUBA Diving Computers Due to Injury and Drowning Hazards
Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding
TMC Acquisition LLC dba Tailor Made Compounding
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
Waldemar Link GmbH & Co. KG (Mfg Site)
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Ventana Medical Systems Inc
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Wright Medical Technology, Inc.
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Isopure Corp
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
ProxiDiagnost N90. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
MiniMed 640G Insulin Pump (O.U.S. Version)
Medtronic MiniMed
MiniMed 740G Insulin Pump (O.U.S. Version)
Medtronic MiniMed
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
Waldemar Link GmbH & Co. KG (Mfg Site)
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Zeltiq Aesthetics, Inc
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Invacare Corporation
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Zeltiq Aesthetics, Inc
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Spectranetics Corporation
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
Siemens Healthcare Diagnostics Inc
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
Zeltiq Aesthetics, Inc
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Zeltiq Aesthetics, Inc
Ivenix Infusion System (IIS)
Ivenix, Inc.
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Cook Incorporated
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Fresenius Medical Care Holdings, Inc.
MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
Medtronic MiniMed
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
SCIENCE & BIO MATERIALS
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
Alcon Research, LLC
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
Fresenius Medical Care Holdings, Inc.
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
Breas Medical, Inc.
MiniMed 720G Insulin Pump (O.U.S. Version)
Medtronic MiniMed
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Zeltiq Aesthetics, Inc
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Draeger Medical Systems, Inc.
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
Agilent Technologies, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
Fresenius Medical Care Holdings, Inc.
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
MiniMed 780G Insulin Pump (O.U.S. Version)
Medtronic MiniMed
MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
Medtronic MiniMed
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Waldemar Link GmbH & Co. KG (Mfg Site)
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000
DePuy Orthopaedics, Inc.
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.