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 · 2026-09-03
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 740 of 822
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of pheny…
Siemens Healthcare Diagnostics, Inc
The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to…
Stryker Medical Division of Stryker Corporation
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. …
GE Healthcare, LLC
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessori…
Medtronic Advanced Energy, LLC
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIA…
Nipro Diagnostics, Inc.
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy Sy…
ArjoHuntleigh Inc.
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for…
OrthoPediatrics Corp
Neptune 2 Rover Ultra Waste Management System.
Stryker Instruments Div. of Stryker Corporation
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepa…
Horiba Instruments, Inc dba Horiba Medical
Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723*…
GE Healthcare
Neptune 2 Rover Ultra Waste Management System
Stryker Instruments Div. of Stryker Corporation
Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman R…
GE Healthcare
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Edwards Lifesciences, LLC
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: A…
Alexion Pharmaceuticals, Inc.
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
The Anspach Effort, Inc.
S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures last…
Sorin Group Deutschland GmbH
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is de…
Becton Dickinson & Co.
23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O…
Synergetics Inc
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray …
Philips Medical Systems (Cleveland) Inc
25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon…
Synergetics Inc
23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'F…
Synergetics Inc
23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, I…
Synergetics Inc
Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synerget…
Synergetics Inc
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. …
DeRoyal Industries Inc
T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 …
Siemens Healthcare Diagnostics
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generati…
Carestream Health Inc.
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN …
Codman & Shurtleff, Inc.
27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetic…
Synergetics Inc
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined M…
Siemens Healthcare Diagnostics, Inc.
Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CO…
Codman & Shurtleff, Inc.
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/T…
Navilyst Medical, Inc.
Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, In…
Synergetics Inc
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 …
Siemens Medical Solutions USA, Inc.
25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon…
Synergetics Inc
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Pro…
Codman & Shurtleff, Inc.
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk L…
DeRoyal Industries Inc
23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O…
Synergetics Inc
T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 103…
Siemens Healthcare Diagnostics
Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integr…
Focus Diagnostics Inc
23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for …
Synergetics Inc
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use …
GE Healthcare, LLC
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhali…
Biomerieux France Chemin De L'Or
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN…
Codman & Shurtleff, Inc.
Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per b…
Synergetics Inc
Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Syner…
Synergetics Inc
25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O…
Synergetics Inc
Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable …
Codman & Shurtleff, Inc.
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicat…
GE Healthcare, LLC
Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the spec…
Maquet Cardiovascular Us Sales, Llc
Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon,…
Synergetics 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.