Product category · Updated Aug 19, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
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
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06
AVID Medical, Inc.
Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
AVID Medical, Inc.
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
Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
AVID Medical, Inc.
Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02
AVID Medical, Inc.
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
AVID Medical, Inc.
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
AVID Medical, Inc.
Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15
AVID Medical, Inc.
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
AVID Medical, Inc.
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Boston Scientific Corporation
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.
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
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
AVID Medical, Inc.
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
AVID Medical, Inc.
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
MEDLINE INDUSTRIES, LP - Northfield
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
Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03
AVID Medical, Inc.
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
MEDLINE INDUSTRIES, LP - Northfield
Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05
AVID Medical, Inc.
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
Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04
AVID Medical, Inc.
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03
AVID Medical, Inc.
Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19
AVID Medical, Inc.
Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
AVID Medical, Inc.
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Boston Scientific Corporation
ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
MEDLINE INDUSTRIES, LP - Northfield
Halyard ENT - Medical convenience kits Model Number: VMED011-01
AVID Medical, Inc.
Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
AVID Medical, Inc.
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.
Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
AVID Medical, Inc.
Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
AVID Medical, Inc.
Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13
AVID Medical, Inc.
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
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
URINE KIT, SKU DYKM1845; Component No. 503581
MEDLINE INDUSTRIES, LP - Northfield
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
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.
Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04
AVID Medical, Inc.
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
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02
AVID Medical, Inc.
Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06
AVID Medical, Inc.
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
Philips Zenition 50, Model Number: 718096
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13
AVID Medical, Inc.
Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06
AVID Medical, Inc.
Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05
AVID Medical, Inc.
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
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
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.
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
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
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.