Product category · Updated Jul 29, 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 (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
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 576 of 819
Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device …
Ortho-Clinical Diagnostics
Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in…
Osteogenics Biomedical, Inc.
Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid st…
Synergetics Inc
Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and p…
Randox Laboratories Ltd.
Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Calix P PEEK Lumbar System, PLIF Trial
X Spine Systems Inc
Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for…
Windstone Medical Packaging, Inc.
Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, I…
Ortho-Clinical Diagnostics
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating …
Windstone Medical Packaging, Inc.
OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surger…
Windstone Medical Packaging, Inc.
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3…
Windstone Medical Packaging, Inc.
GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84X…
ConMed Corporation
D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, 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 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.