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 310 of 819

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Moderate Dec 30, 2020

30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red …

ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020

Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO …

Haag-Streit USA Inc
FDA Devices Moderate Dec 30, 2020

IceEDGE" 2.4¿ 90p¿ Cryoablation Needle

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceSeed" Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patien…

B Braun Medical, Inc.
FDA Devices Moderate Dec 30, 2020

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag…

ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020

31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin …

ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020

Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020

Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX L 90¿ Cryoablation Needle

Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 MRI Cryoablation Needle¿

Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Critical Dec 30, 2020

Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding S…

Cook Inc.
FDA Devices Moderate Dec 30, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fl…

Baxter Healthcare Corporation
FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Moderate Dec 30, 2020

Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of…

Biocomposites, Ltd.
FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Moderate Dec 30, 2020

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe …

GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milw…

GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 90¿ Cryoablation Needle

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 90¿ Cryoablation Needle

Boston Scientific Corporation
FDA Devices Low Dec 30, 2020

AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103,…

Applied Medical Technology Inc
FDA Devices Moderate Dec 30, 2020

ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020

STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WAL…

GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020

STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code:…

GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020

3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, RE…

ICU Medical, Inc.
FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 PLUS Cryoablation Needle

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceRod" Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 Cryoablation Needle

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceRod" i-Thaw" Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX Cryoablation Needle

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 Cryoablation Needle

Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX L 90¿ Cryoablation Needle

Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheaths are intended to introduc…

Cook Inc.
FDA Devices Moderate Dec 30, 2020

IceRod" He-Thaw Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceSeed" Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) …

Prytime Medical Devices, Inc.
FDA Devices Moderate Dec 30, 2020

IceRod" i-Thaw" Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 MRI 90¿ Cryoablation Needle¿

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX Prostate Cryoablation Kit

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿

Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 90¿ Cryoablation Needle

Boston Scientific 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.

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.