PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

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

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
total recalls
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

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 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 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 161 of 808

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260

Family Dollar Stores, Llc.

FDA Devices Moderate Nov 15, 2023

RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.

Encore Medical, LP

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to…

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system

Philips North America Llc

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

FDA Devices Moderate Nov 15, 2023

THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for int…

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

FDA Devices Moderate Nov 15, 2023

Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm

Securitas Healthcare LLC

FDA Devices Moderate Nov 15, 2023

CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and hear…

St. Jude Medical

FDA Devices Moderate Nov 15, 2023

EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

FDA Devices Critical Nov 15, 2023

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180

Olympus Corporation of the Americas

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010

Stryker Corporation

FDA Devices Critical Nov 15, 2023

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

Olympus Corporation of the Americas

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

Securitas Healthcare LLC

FDA Devices Moderate Nov 15, 2023

30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023

Family Dollar Stores, Llc.

FDA Devices Critical Nov 15, 2023

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC

Olympus Corporation of the Americas

FDA Devices Moderate Nov 15, 2023

AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

Zenition 50 & 70 Mobile Surgery C-arm

Philips North America

FDA Devices Critical Nov 15, 2023

Novum IQ Syringe infusion system, Product Code 40800BAXUS

Baxter Healthcare Corporation

FDA Devices Moderate Nov 15, 2023

AT HOME MARIJUANA TEST STRIP, SKU 900752

Family Dollar Stores, Llc.

FDA Devices Critical Nov 15, 2023

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Cordis US Corp

FDA Devices Moderate Nov 15, 2023

FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239

Family Dollar Stores, Llc.

FDA Devices Moderate Nov 15, 2023

ORAL B MOUTH SORE RINSE 237ML, SKU 999087

Family Dollar Stores, Llc.

FDA Devices Moderate Nov 15, 2023

Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

Alcon Research, LLC

FDA Devices Moderate Nov 15, 2023

30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

Azurion IGTS Fixed Systems

Philips North America

FDA Devices Moderate Nov 15, 2023

FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

CHANGE HEALTHCARE CANADA COMPANY

FDA Devices Moderate Nov 15, 2023

Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 7952…

Philips Ultrasound, Inc.

FDA Devices Moderate Nov 15, 2023

Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010

Stryker Corporation

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

FDA Devices Moderate Nov 15, 2023

SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.

B. Braun Medical, Inc.

FDA Devices Moderate Nov 15, 2023

CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles

Young Dental Manufacturing I, LLC

FDA Devices Critical Nov 15, 2023

StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as…

Medtronic Navigation, Inc.

FDA Devices Moderate Nov 15, 2023

Integris-Allura IGTS Fixed Systems

Philips North America

FDA Devices Moderate Nov 15, 2023

BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

Breg 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 2, 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 2, 2026.