Product category · Updated Jul 29, 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 (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.
- 40,910 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 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- 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
40,910 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 · NHTSA federal recall filings · 2026-08-29
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 637 of 819
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Innokas Medical Oy
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers a…
Stryker Sustainability Solutions
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner fo…
GE Healthcare
MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Siemens Medical Solutions USA, Inc
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device…
GE Healthcare
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Beckman Coulter Inc.
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and…
Miramar Labs, Inc.
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Cook Inc.
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP02004…
Medtronic Vascular, Inc.
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Synthes (USA) Products LLC
Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elem…
Maquet Cardiovascular Us Sales, Llc
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging d…
GE Healthcare
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal …
Stryker Howmedica Osteonics Corp.
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Teleflex Medical
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Ceterix Orthopedics, Inc.
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Stryker Howmedica Osteonics Corp.
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 8…
DeRoyal Industries Inc
Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Po…
Maquet Cardiovascular Us Sales, Llc
R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
Teleflex Medical
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emis…
GE Healthcare
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
NeuroLogica Corporation
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Focus Diagnostics Inc
GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Sign…
GE Healthcare
MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to man…
CooperSurgical, Inc.
Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant moun…
Biomet 3i, LLC
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials…
Utah Medical Products, Inc
Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, hea…
Biomet 3i, LLC
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Tekia, Inc.
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
GE Medical Systems, LLC
Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
Barco Inc.
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images…
GE Healthcare
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-bas…
Biomet Spine, LLC
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Alcon Research, Ltd.
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Comput…
Philips Medical Systems (Cleveland) Inc
Robotic hand accessory to InMotion Arm, rehabilitation robot.
Interactive Motion Technologies, Inc.
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tournique…
Pyng Medical Corporation
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product refer…
ELITech Clinical Systems SAS
BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30…
Bausch & Lomb Inc Irb
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee re…
Mako Surgical Corporation
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
Otto Bock Healthcare GmbH
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ,…
Siemens Medical Solutions USA, Inc.
Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (A…
ELITech Clinical Systems SAS
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent…
Ivoclar A. G.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Philips Medical Systems, Inc.
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Baxter Healthcare Corp.
HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The Heart…
Philips Medical Systems, Inc.
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 5543…
ELITech Clinical Systems SAS
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ve…
Hamilton Medical, Inc.
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision …
Dako North America Inc.
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Exactech, 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 Jul 29, 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 29, 2026.