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
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

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

40,910 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · NHTSA federal recall filings · 2026-08-27

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 578 of 819

FDA Devices Moderate Oct 26, 2016

General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Plastic General Pack, Kit number AMS4215 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynec…

ConMed Corporation

FDA Devices Moderate Oct 26, 2016

Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Critical Oct 26, 2016

Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and mon…

Leonhard Lang Medizintechnik GmbH

FDA Devices Moderate Oct 26, 2016

RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of t…

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Oct 26, 2016

Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use b…

Tearscience, Inc

FDA Devices Moderate Oct 26, 2016

Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating r…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating r…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general sur…

Windstone Medical Packaging, Inc.

FDA Drug Moderate Oct 19, 2016

morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharM…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Produ…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product cod…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only,…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume …

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, P…

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104.

Pharmedium Services, LLC

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 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.