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 128 of 808

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295

Philips North America Llc

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Achieva 1.5T Initial system Model Number (REF): 781178

Philips North America Llc

FDA Devices Moderate May 29, 2024

Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for s…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for sin…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439

Philips North America Llc

FDA Devices Moderate May 29, 2024

8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional en…

Stryker Leibinger GmbH & Co. KG

FDA Devices Moderate May 29, 2024

Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for s…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles for sing…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781…

Philips North America Llc

FDA Devices Critical May 29, 2024

OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R111112…

Philips Respironics, Inc.

FDA Devices Moderate May 29, 2024

Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needles for s…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for sin…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Critical May 29, 2024

BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111…

Philips Respironics, Inc.

FDA Devices Moderate May 29, 2024

Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for s…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate May 29, 2024

Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for s…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 7812…

Philips North America Llc

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syringes without needles for sin…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for …

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for s…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles for sing…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350

Philips North America Llc

FDA Devices Moderate May 29, 2024

Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782…

Philips North America Llc

FDA Devices Moderate May 29, 2024

Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The …

Channel Medsystems, Inc.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles f…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly duri…

Olympus Corporation of the Americas

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for sin…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles f…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Sterile syringes without needles f…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Critical May 29, 2024

Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use C…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 78…

Philips North America Llc

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for s…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474

Philips North America Llc

FDA Devices Moderate May 29, 2024

Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

YAMAHA MOTOR CORPORATION

FDA Devices Moderate May 29, 2024

Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271

Philips North America Llc

FDA Devices Moderate May 29, 2024

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

Ethicon, Inc.

FDA Devices Moderate May 29, 2024

SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Numb…

Philips North America Llc

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles for sing…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile syringes without needles for si…

Jiangsu Shenli Medical Production Co., Ltd.

FDA Devices Moderate May 29, 2024

Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF):…

Philips North America Llc

FDA Devices Moderate May 29, 2024

Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for s…

Jiangsu Shenli Medical Production Co., Ltd.

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.