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 · 2026-09-02
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 716 of 822
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, displ…
Mckesson Medical Immaging
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
DeRoyal Industries Inc
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System fo…
Medtronic Neuromodulation
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
Ra Medical Systems Inc
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal proced…
Nidek Inc
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" can…
Small Bone Innovations
Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
Novocol, Inc.
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate.…
Zimmer, Inc.
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
DeRoyal Industries Inc
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Siemens Healthcare Diagnostics, Inc.
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally…
Baxter Healthcare Corporation
InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
Stryker Medical Division of Stryker Corporation
Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163,…
Franck's Lab Inc dba Trinity Care Solutions
Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, …
Franck's Lab Inc dba Trinity Care Solutions
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician wi…
AGFA Corp.
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Can…
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous …
Terumo Cardiovascular Systems Corporation
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated…
Terumo Cardiovascular Systems Corporation
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return C…
Terumo Cardiovascular Systems Corporation
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acqui…
Philips Ultrasound, Inc.
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument…
DePuy Orthopaedics, Inc.
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ve…
Teleflex Medical
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, pro…
Siemens Medical Solutions USA, Inc
MK5 NX Controller--Wheelchair controller
Invacare Corporation
Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consi…
Zoll Circulation, Inc.
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the asc…
Terumo Cardiovascular Systems Corporation
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODUL…
GE Healthcare, LLC
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circ…
Teleflex Medical
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the D…
DePuy Orthopaedics, Inc.
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator elect…
Heartsine Technologies, Limited
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascend…
Terumo Cardiovascular Systems Corporation
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip join…
Exactech, Inc.
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provi…
Stryker Endoscopy
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Retur…
Terumo Cardiovascular Systems Corporation
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
ITC-Nexus Dx
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 50…
Siemens Healthcare Diagnostics Inc
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
GE Healthcare, LLC
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Biogenex Laboratories, Inc.
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a prof…
GE Healthcare, LLC
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in…
Terumo Cardiovascular Systems Corporation
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system inte…
Alphatec Spine, Inc.
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gast…
Pentax Medical Company
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon ca…
Perouse Medical
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Synthes, Inc.
CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation…
Terumo Cardiovascular Systems Corporation
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap F…
Salter Labs
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquire…
Philips Ultrasound, Inc.
Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: …
Terumo Cardiovascular Systems Corporation
Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aor…
Terumo Cardiovascular Systems Corporation
RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used t…
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.