PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

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

Total recalls
41,070
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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-24

Do more recalls mean more Class I danger?

Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-24. 2×2 strategic matrix plotting 7 entities by Total recalls (count) (X) and Class I share of classified (%) (Y), with a crosshair dividing the plot into four quadrants. Large · Class I–heavySmaller · Class I–heavyLarge · fewer Class ISmaller · fewer Class I 010,00020,00030,00040,00050,000 0%20%40%60%80% Total recalls (count) Class I share of classified (%) Category volume vs Class I rate Signature insight Medical DevicesFoodDrugs & MedicationsChildren & Baby ProductsDietary SupplementsMeat & PoultryCosmetics & Personal Care
Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-24.
Read the chart, every category as text

Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.

CategoryRecallsVol %ileClassifiedClass IClass I %Rate %ile
Medical Devices41,07010040,7633,6539%14
Food25,5138625,22211,67646.3%86
Drugs & Medications14,4737114,4171,50810.5%29
Children & Baby Products4,017572,48335214.2%43
Dietary Supplements2,018431,99346623.4%71
Meat & Poultry1,672291,6721,14568.5%100
Cosmetics & Personal Care1,388141,28920315.7%57

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 106 of 822

FDA Devices Moderate Nov 20, 2024

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Catalog Number: 0703

Stryker Corporation

FDA Devices Moderate Nov 20, 2024

Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16

AVID Medical, Inc.

FDA Devices Critical Nov 20, 2024

Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010

Boston Scientific Corporation

FDA Devices Critical Nov 20, 2024

Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

Philips Respironics, Inc.

FDA Devices Moderate Nov 20, 2024

CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

The Metrix Company

FDA Devices Moderate Nov 20, 2024

Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Nov 20, 2024

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0

Getinge Usa Sales Inc

FDA Devices Moderate Nov 20, 2024

Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Nov 20, 2024

Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0

Getinge Usa Sales Inc

FDA Devices Moderate Nov 20, 2024

Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02

AVID Medical, Inc.

FDA Devices Critical Nov 20, 2024

Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

Boston Scientific Corporation

FDA Devices Moderate Nov 20, 2024

ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Nov 20, 2024

Halyard ENT - Medical convenience kits Model Number: VMED011-01

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04

AVID Medical, Inc.

FDA Devices Critical Nov 20, 2024

Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

Philips Respironics, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

The Metrix Company

FDA Devices Moderate Nov 20, 2024

SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

The Metrix Company

FDA Devices Moderate Nov 20, 2024

URINE KIT, SKU DYKM1845; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Nov 20, 2024

SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

The Metrix Company

FDA Devices Critical Nov 20, 2024

LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

Philips Respironics, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

The Metrix Company

FDA Devices Moderate Nov 20, 2024

Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

The Metrix Company

FDA Devices Moderate Nov 20, 2024

Philips Zenition 50, Model Number: 718096

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Nov 20, 2024

Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05

AVID Medical, Inc.

FDA Devices Moderate Nov 20, 2024

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2

Getinge Usa Sales Inc

FDA Devices Moderate Nov 20, 2024

Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G

Cook Incorporated

FDA Devices Critical Nov 20, 2024

Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

Philips Respironics, Inc.

FDA Devices Critical Nov 20, 2024

microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

FHC, 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 Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.