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 745 of 822
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made…
Integra LifeSciences Corp.
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solution…
Ansell Sandel Medical Industries LLC
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connect…
ICU Medical, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Need…
Smiths Medical ASD, Inc.
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connec…
ICU Medical, Inc.
7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 Th…
ICU Medical, Inc.
8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use…
ICU Medical, Inc.
120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 2 Ext, Part No. …
ICU Medical, Inc.
NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile,…
ICU Medical, Inc.
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
The Anspach Effort, Inc.
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
SpineFrontier, Inc.
7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is…
ICU Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use…
ICU Medical, Inc.
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The IC…
ICU Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Conn…
ICU Medical, Inc.
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A,…
Optimedica Corporation
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
EOS Imaging
Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solution…
Ansell Sandel Medical Industries LLC
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT …
Materialise USA LLC
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acut…
Fresenius Medical Care Holdings, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Need…
Smiths Medical ASD, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless…
ICU Medical, Inc.
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device wi…
Alere San Diego, Inc.
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solution…
Ansell Sandel Medical Industries LLC
17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Connector …
ICU Medical, Inc.
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
GE Healthcare, LLC
***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
The Anspach Effort, Inc.
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Sol…
Ansell Sandel Medical Industries LLC
184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave¿, NanoClave¿ TConnector, Rotating…
ICU Medical, Inc.
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made…
Integra LifeSciences Corp.
10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The ICU Nee…
ICU Medical, Inc.
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical …
Covidien
30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 1 Ext, Part No. A1000,…
ICU Medical, Inc.
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a…
Trans American Medical, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed Need…
Smiths Medical ASD, Inc.
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolu…
Carestream Health Inc.
10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer,…
ICU Medical, Inc.
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector …
ICU Medical, Inc.
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP)…
Welch Allyn Protocol, Inc
5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a s…
ICU Medical, Inc.
6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating…
ICU Medical, Inc.
13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connecto…
ICU Medical, Inc.
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C…
Siemens Healthcare Diagnostics, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand…
Smiths Medical ASD, Inc.
7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intende…
ICU Medical, Inc.
87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave¿, Part No. A…
ICU Medical, Inc.
Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
ArthroCare Medical Corporation
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is…
ICU Medical, Inc.
8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Ite…
ICU Medical, Inc.
Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05S…
The Anspach Effort, 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.