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 · 2026-09-04
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 809 of 822
BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Qu…
Becton Dickinson & Co.
Death of Child Prompts Recall of Window Blinds by Blind Xpress
Blind Xpress of Livonia, Mich.
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0…
Hospira Inc.
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiri…
Bard Access Systems
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY*…
Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY…
Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents:…
Unimed Surgical Products, Inc.
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibra…
Siemens Healthcare Diagnostics, Inc.
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes…
Baxter Healthcare Corp.
Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San…
Cisco Systems Inc
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns …
Philips Healthcare Inc.
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Phadia US Inc
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cy…
Biomet 3i, LLC
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automat…
Advanced Sterilization Products
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1…
Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81 ) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY*…
Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: …
Unimed Surgical Products, Inc.
EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiograp…
Toshiba American Medical Systems Inc
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Sunquest Information Systems, Inc.
Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved…
Toshiba American Medical Systems Inc
Sunquest Laboratory LabAccess Results Workstation (LARS)
Sunquest Information Systems, Inc.
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Steris Corporation
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1…
Unimed Surgical Products, Inc.
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two …
Advanced Neuromodulation Systems Inc.
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure tr…
SRI Surgical
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexf…
Unimed Surgical Products, Inc.
CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of…
Metrex Research, LLC.
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended t…
Canon Inc.
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervisi…
Mindray DS USA, Inc. d.b.a. Mindray North America
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents…
Unimed Surgical Products, Inc.
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; …
Baxter Healthcare Corp.
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The pro…
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY*…
Unimed Surgical Products, Inc.
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a si…
Toshiba American Medical Systems Inc
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Siemens Medical Solutions USA, Inc
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary…
Alphatec Spine, Inc.
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 700…
I-Flow Corporation
syngo Imaging XS. Radiological image processing system.
Siemens Medical Solutions USA, Inc
Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product …
Advanced Neuromodulation Systems Inc.
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80…
Sendx Medical Inc
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match th…
Encore Medical, Lp
Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY…
Unimed Surgical Products, Inc.
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture a…
GE OEC Medical Systems, Inc
Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter…
Atlas Spine, Inc.
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay …
Siemens Healthcare Diagnostics, Inc
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the …
DePuy Orthopaedics, Inc.
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right K…
Conformis Inc
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to…
Stryker Medical Division of Stryker Corporation
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human s…
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vit…
Beckman Coulter 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.