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 105 of 822
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
MEDLINE INDUSTRIES, LP - Northfield
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
MEDLINE INDUSTRIES, LP - Northfield
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of pos
Topcon Medical Systems, Inc.
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
AVID Medical, Inc.
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
The Metrix Company
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Draeger Medical, Inc.
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
AVID Medical, Inc.
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. 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 UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02
AVID Medical, Inc.
Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
AVID Medical, Inc.
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
The Metrix Company
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Siemens Healthcare Diagnostics, Inc.
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
WISSNER-BOSSERHOFF GMBH
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Boston Scientific Corporation
Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
AVID Medical, Inc.
Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04
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: 710001B0
Getinge Usa Sales Inc
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
The Metrix Company
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: 720001F0
Getinge Usa Sales Inc
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
AVID Medical, Inc.
Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
AVID Medical, Inc.
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Draeger Medical, Inc.
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Boston Scientific Corporation
Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29
AVID Medical, Inc.
Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
AVID Medical, Inc.
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tapered dilator intended to establish a conduit for the passage of endoscopes and retrieval devices
Olympus Corporation of the Americas
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Boston Scientific Corporation
Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
AVID Medical, Inc.
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
AVID Medical, Inc.
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
MEDLINE INDUSTRIES, LP - Northfield
Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
AVID Medical, Inc.
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
The Metrix Company
Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19
AVID Medical, Inc.
Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005
AVID Medical, Inc.
Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
AVID Medical, Inc.
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
The Metrix Company
Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
AVID Medical, Inc.
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Cardinal Health 200, LLC
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. 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.
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - 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. Catalog Number: 0703-046-000
Stryker Corporation
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
The Metrix Company
Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
AVID Medical, Inc.
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
AVID Medical, Inc.
Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
AVID Medical, Inc.
Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
AVID Medical, Inc.
Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29
AVID Medical, Inc.
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Cook Incorporated
UA KIT, SKU DYKM1690A; Component No. 503581
MEDLINE INDUSTRIES, LP - Northfield
Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
AVID Medical, Inc.
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Karl Storz Endoscopy
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.