PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

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 · 2026-08-25

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 539 of 819

FDA Devices Moderate May 17, 2017

Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

Zimmer Biomet, Inc.

FDA Devices Moderate May 17, 2017

Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

Arthrex, Inc.

FDA Devices Moderate May 17, 2017

Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

Mentor Texas, LP.

FDA Devices Moderate May 17, 2017

Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatc…

Greatbatch Medical

FDA Devices Moderate May 17, 2017

Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate May 17, 2017

MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purpos…

Med-Hot Thermal Imaging, Inc.

FDA Devices Moderate May 17, 2017

Medi-Therm Hyper/Hypothermia System, MTA7900

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate May 17, 2017

Healon 5 Pro, Part No. 10270015

Abbott Medical Optics Inc. (AMO)

FDA Devices Moderate May 17, 2017

Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701

Abbott Medical Optics Inc. (AMO)

FDA Devices Moderate May 17, 2017

Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product …

Zimmer Biomet, Inc.

FDA Devices Moderate May 17, 2017

Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702…

Roche Diagnostics Corporation

FDA Devices Moderate May 17, 2017

Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments ar…

Almore International Inc

FDA Devices Moderate May 17, 2017

Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012

Abbott Medical Optics Inc. (AMO)

FDA Devices Moderate May 17, 2017

PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew,…

Smith & Nephew, Inc.

FDA Devices Moderate May 17, 2017

Healon V, Part No. 10290045

Abbott Medical Optics Inc. (AMO)

FDA Devices Moderate May 17, 2017

Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

Arthrex, Inc.

FDA Devices Moderate May 17, 2017

Bone Dowell Harvest Tubes

Zimmer Biomet, Inc.

FDA Devices Moderate May 17, 2017

CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnfla…

CooperSurgical, Inc.

FDA Devices Moderate May 17, 2017

Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

Arthrex, Inc.

FDA Devices Moderate May 17, 2017

Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

Arthrex, Inc.

FDA Devices Moderate May 17, 2017

Savaria SL-1000 Stairlift

Savaria Concord Lifts, Inc.

CPSC No agency class May 11, 2017

Carrier and Bryant Recall Heat Pumps Due to Fire Hazard

Carrier Corporation, of Jupiter, Fla.

FDA Devices Moderate May 10, 2017

ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technolo…

Roho Inc.

FDA Devices Moderate May 10, 2017

Keyless Driver Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

14cm QD Angle Attachment Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

Electric Handpiece EM Hand Control Product Usage: Electric system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

6.8cm Controlled Depth Attachment Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

SMALL ATTACHMENT, J-LATCH

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)

Smith & Nephew, Inc.

FDA Devices Moderate May 10, 2017

IMRI AIR CONTROL Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

14cm QD Angle Attachment Product Usage: Product attachment

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

XMAX Motor, High Strength Hose Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan

Sysmex America Inc

FDA Devices Moderate May 10, 2017

12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

Rotating Adult Craniotome Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson …

Becton Dickinson & Company

FDA Devices Moderate May 10, 2017

Foot Control without Switches, SC2100 Product Usage: Electric system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)

Smith & Nephew, Inc.

FDA Devices Moderate May 10, 2017

Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therap…

Breg Inc

FDA Devices Moderate May 10, 2017

Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Dif…

Richard-Allan Scientific Company

FDA Devices Moderate May 10, 2017

STANDARD CRANIOTOME, BLACK MAX

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

11cm QD Angle Attachment Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

System Console, Single Port, with irrigation Product Usage: Electric system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

Rotating Large Craniotome

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of a…

Bard Peripheral Vascular Inc

FDA Devices Moderate May 10, 2017

BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

IMRI SHORT ATTACHMENT Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

90 degree Contra Angle Attachment Product Usage: Pneumatic system

The Anspach Effort, Inc.

FDA Devices Moderate May 10, 2017

Foot control irrigation system Product Usage: Pneumatic system

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

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.