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 335 of 819

FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functi…

Mediana Co., Ltd.
FDA Devices Moderate Jul 8, 2020

Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107

LivaNova USA Inc.
FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500

Arrow International Inc
FDA Devices Critical Jul 8, 2020

Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

Arrow International Inc
FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

Arrow International Inc
FDA Devices Moderate Jul 8, 2020

Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 …

Ortho Organizers, Inc.
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF …

Westmed, Inc.
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Respirator Crash Cart Kit

ROi CPS LLC
FDA Devices Moderate Jul 8, 2020

PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W8…

Ethicon, Inc.
FDA Devices Moderate Jul 8, 2020

(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 8, 2020

VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

Ortho Clinical Diagnostics
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320

LivaNova USA Inc.
FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

Arrow International Inc
FDA Devices Moderate Jul 8, 2020

CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label i…

Codan US Corporation
FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL

Arrow International Inc
FDA Devices Moderate Jul 8, 2020

Isolation Droplet Bundle Kit

ROi CPS LLC
FDA Devices Moderate Jul 8, 2020

Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

Baxter Healthcare Corporation
FDA Devices Moderate Jul 8, 2020

Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laborato…

Siemens Healthcare Diagnostics Inc.
FDA Devices Moderate Jul 8, 2020

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

Elekta Instrument AB
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484

Ortho Organizers, Inc.
FDA Devices Moderate Jul 8, 2020

3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Leng…

Westmed, Inc.
FDA Devices Moderate Jul 8, 2020

3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110

Ortho Clinical Diagnostics
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

Smiths Medical ASD Inc.
FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I

Arrow International Inc
FDA Devices Moderate Jul 8, 2020

VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610

Ortho Clinical Diagnostics
FDA Devices Moderate Jul 8, 2020

Elekta Unity, Image-Guided Radiation Therapy System

Elekta, Inc.
FDA Devices Moderate Jul 8, 2020

Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986

LivaNova Deutschland GmbH
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283

LivaNova USA Inc.
FDA Devices Critical Jul 8, 2020

Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700

Arrow International Inc
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box

Mueller Sports Medicine, Inc
FDA Devices Moderate Jul 8, 2020

BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models B…

Preventice Services, LLC
FDA Devices Moderate Jul 8, 2020

Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

Fujifilm Medical Systems U.S.A., Inc.
FDA Devices Moderate Jul 8, 2020

1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269

LivaNova USA Inc.
FDA Devices Moderate Jul 8, 2020

Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993

LivaNova Deutschland GmbH
FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

Arrow International Inc
FDA Devices Moderate Jul 8, 2020

Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306

LivaNova USA Inc.
FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

Arrow International Inc
FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E

Arrow International Inc
FDA Devices Moderate Jul 8, 2020

1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278

LivaNova USA 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.

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.