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 · 2026-08-22
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 457 of 819
N Latex CDT Kit
CSL Behring GmbH
GE Carestation 30 anesthesia systems
GE Medical Systems China Co., Ltd.
DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
Medical Components, Inc dba MedComp
GE 9100c NXT anesthesia systems
GE Medical Systems China Co., Ltd.
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
Stryker Mako Vizadisc Hip Procedure Tracking Kit
Mako Surgical Corporation
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 …
Siemens Healthcare Diagnostics, Inc.
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system…
Haemonetics Corporation
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used…
Sysmex America, Inc.
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
Medical Components, Inc dba MedComp
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Smith & Nephew, Inc.
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
Philips Medical Systems Gmbh, DMC
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
Philips Medical Systems Gmbh, DMC
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. …
Civco Medical Instruments Co. Inc.
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The…
Philips Electronics North America Corporation
Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where …
Philips Electronics North America Corporation
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cy…
Euro Diagnostica AB
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
Philips Medical Systems Gmbh, DMC
DigitalDiagnost Single Detector (Stitching Patient Support) 712020
Philips Medical Systems Gmbh, DMC
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
Philips Medical Systems Gmbh, DMC
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Philips Medical Systems Gmbh, DMC
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and s…
TriMed Inc.
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Philips Medical Systems Gmbh, DMC
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobili…
Back 2 Basics Direct LLC
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
Philips Medical Systems Gmbh, DMC
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axess…
Elekta, Inc.
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
Philips Medical Systems Gmbh, DMC
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Philips Medical Systems Gmbh, DMC
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin …
bioMerieux, Inc.
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
Philips Medical Systems Gmbh, DMC
Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever t…
Philips Electronics North America Corporation
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedur…
Zimmer Biomet, Inc.
GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only ou…
GE Healthcare Japan Corporation
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in hu…
Euro Diagnostica AB
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Philips Medical Systems Gmbh, DMC
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid…
Euro Diagnostica AB
3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is movea…
Siemens Medical Solutions USA, Inc
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP…
Compass Health Brands (Corporate Office)
DigitalDiagnost Upgrades (Stitching Patient Support) 712083
Philips Medical Systems Gmbh, DMC
Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 an…
Johnson & Johnson Vision Care, Inc.
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies spe…
Euro Diagnostica AB
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
Philips Medical Systems Gmbh, DMC
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multip…
Arrow International Inc
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be use…
Ortho Kinematics, Inc
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomograph…
Hitachi Medical Systems America Inc
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
Philips Medical Systems Gmbh, DMC
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
Philips Medical Systems Gmbh, DMC
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.