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
Compiled from official public sources by the editorial process.
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

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 376 of 819

FDA Devices Moderate Dec 11, 2019

Quantam 2000 Electrosurgical Generator, Part number 909075-05.

CooperSurgical, Inc.
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Sl…

Beckman Coulter, Inc.
FDA Devices Moderate Dec 4, 2019

ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Abbott Gmbh & Co. KG
FDA Devices Moderate Dec 4, 2019

COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 P…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Produ…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate impl…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HA…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Comprehensive RS Cleat CAP, Item No. 110300

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

PRO-STIM 10cc INJECTABLE, Part Number 86SR0410

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm nam…

Spectranetics Corporation
FDA Devices Moderate Dec 4, 2019

LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices …

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Atellica CH 930 Analyzer

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Dec 4, 2019

Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a p…

Nextremity Solutions
FDA Devices Moderate Dec 4, 2019

HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

SWANSON FINGER JOINT #1, Part Number 4700001

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

INBONE STEM, TIBIAL, TOP, Part Number 200011901

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH…

GN Hearing A/S
FDA Devices Moderate Dec 4, 2019

Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP11…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tool…

ENDOTRONIX
FDA Devices Moderate Dec 4, 2019

NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350…

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Rocket Medical Plc
FDA Devices Moderate Dec 4, 2019

CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.

Medline Industries Inc
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

Vital Scientific N.V.
FDA Devices Moderate Dec 4, 2019

Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; …

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

SWANSON TRAPEZIUM IMPLANT, Part Number 4520002

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

Abbott Gmbh & Co. KG
FDA Devices Moderate Dec 4, 2019

ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 17…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada

Abbott GmBH & Co. KG
FDA Devices Moderate Dec 4, 2019

Alinity ci Level Sensor, Bulk Solution

Abbott Gmbh & Co. KG

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.

Food

25,473 recalls →

Drugs & Medications

14,437 recalls →

Vehicles

8,940 recalls →

Children & Baby Products

4,007 recalls →

Household Products

3,567 recalls →

Dietary Supplements

2,016 recalls →

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.