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 · 2026-08-24

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 504 of 819

FDA Devices Moderate Feb 14, 2018

Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclea…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Feb 14, 2018

Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Tip and Tear D…

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 14, 2018

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2

Covidien LLC

FDA Devices Moderate Feb 14, 2018

Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Gene…

Angiodynamics, Inc.

FDA Devices Moderate Feb 14, 2018

Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclero…

Cardiovascular Systems Inc

FDA Devices Moderate Feb 14, 2018

ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Feb 14, 2018

Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear D…

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 14, 2018

Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator…

Angiodynamics, Inc.

FDA Devices Moderate Feb 14, 2018

DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 14, 2018

Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

FDA Devices Moderate Feb 14, 2018

6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: …

Medical Components, Inc dba MedComp

FDA Devices Moderate Feb 14, 2018

Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

FDA Devices Moderate Feb 14, 2018

Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, RE…

Angiodynamics, Inc.

FDA Devices Moderate Feb 14, 2018

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2

Covidien LLC

FDA Devices Moderate Feb 14, 2018

Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedu…

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

FDA Devices Moderate Feb 14, 2018

SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy prote…

ConvaTec, Inc

FDA Devices Moderate Feb 14, 2018

VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS The…

Cyberonics, Inc

FDA Devices Moderate Feb 14, 2018

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1

Covidien LLC

FDA Devices Moderate Feb 14, 2018

Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

FDA Devices Moderate Feb 14, 2018

ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131…

3M Company - Health Care Business

FDA Devices Moderate Feb 14, 2018

BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Feb 14, 2018

BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging ac…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Feb 14, 2018

Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in sk…

Exactech, Inc.

FDA Devices Moderate Feb 14, 2018

Philips Ingenuity CT computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Feb 14, 2018

Philips Ingenuity Core 128 computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Feb 14, 2018

Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum…

The Binding Site Group, Ltd.

FDA Devices Moderate Feb 14, 2018

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1

Covidien LLC

FDA Devices Moderate Feb 14, 2018

Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nucle…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Feb 14, 2018

Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator,…

Angiodynamics, Inc.

FDA Devices Moderate Feb 14, 2018

Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms…

Spacelabs Healthcare Inc

FDA Devices Moderate Feb 14, 2018

Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

FDA Devices Moderate Feb 14, 2018

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2

Covidien LLC

FDA Devices Moderate Feb 14, 2018

TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Feb 7, 2018

Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). …

Edwards Lifesciences, LLC

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.

Carl Zeiss Metrology Inc

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialt…

Beaver-Visitec International Inc.

FDA Devices Moderate Feb 7, 2018

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 7, 2018

MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM

Stryker Medical Division of Stryker Corporation

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.