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 · 2026-08-26
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 553 of 819
Lap Chole Pack (6037) , part number AMS6567
Windstone Medical Packaging, Inc.
D&C/Cysto Pack, part number PSS3257(D
Windstone Medical Packaging, Inc.
Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G
Windstone Medical Packaging, Inc.
Facial Tray, part number PSS1558(A
Windstone Medical Packaging, Inc.
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
Windstone Medical Packaging, Inc.
Foot Pack, part number AMS3637
Windstone Medical Packaging, Inc.
Hip Pack (1347), part number AMS6564
Windstone Medical Packaging, Inc.
Minor Procedure Pack, part number AMS4799
Windstone Medical Packaging, Inc.
Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast …
Windstone Medical Packaging, Inc.
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Cook Inc.
Laminectomy Pack, part number PSS1844(B
Windstone Medical Packaging, Inc.
Morris Hysto Pack, part number PSS3198(A
Windstone Medical Packaging, Inc.
Basic Face Kit, part number PS517A(D
Windstone Medical Packaging, Inc.
Dr. Newman Surgical Procedure Pack, part number PSS1689(A
Windstone Medical Packaging, Inc.
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction o…
Cook Inc.
Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C
Windstone Medical Packaging, Inc.
Basic Kit, part number CMP1109(A
Windstone Medical Packaging, Inc.
Minor Tray, part number AMS2685
Windstone Medical Packaging, Inc.
Dr. Casey Pack, part number AMS4313(A
Windstone Medical Packaging, Inc.
Lap Minor Pack (1346), part number AMS6566
Windstone Medical Packaging, Inc.
Set-Up Pack, part number PSS1305(C
Windstone Medical Packaging, Inc.
Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B
Windstone Medical Packaging, Inc.
Open Procedure Pack II, part number RMS1740(A
Windstone Medical Packaging, Inc.
Basic Tray, part number PSS1559(A
Windstone Medical Packaging, Inc.
Head/Neck Pack, part number AMS6121
Windstone Medical Packaging, Inc.
Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Sh…
Windstone Medical Packaging, Inc.
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …
Siemens Healthcare Diagnostics, Inc
Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C
Windstone Medical Packaging, Inc.
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Matrix Surgical Holdings, LLC
Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(…
Windstone Medical Packaging, Inc.
Reduction Mammoplasty Pack, part number AMS4380 Reduction Mammoplasty Pack, part number AMS4380(B
Windstone Medical Packaging, Inc.
Augmentation Pack, part number AMS6370
Windstone Medical Packaging, Inc.
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment…
Synthes (USA) Products LLC
General Plastics Pack, part number 008617-1
Windstone Medical Packaging, Inc.
Liposuction Pack, part number AMS3323(B Liposuction Pack, part number AMS5684 Liposuction Pack, part number AMS5699
Windstone Medical Packaging, Inc.
Total Knee Pack (15710), part number AMS6563
Windstone Medical Packaging, Inc.
GYN Pack, part number AMS4013(A
Windstone Medical Packaging, Inc.
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163,…
Beckman Coulter Inc.
Lap Pack, part number AMS4801
Windstone Medical Packaging, Inc.
Ocular Plastic Pack, part number AMS3868(A
Windstone Medical Packaging, Inc.
Opgrande Hand Pack, part number AMS4767
Windstone Medical Packaging, Inc.
Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B
Windstone Medical Packaging, Inc.
Extremity Pack (1344), part number AMS6561
Windstone Medical Packaging, Inc.
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introducti…
Cook Inc.
Chest Breast Drape, part number AMS5853
Windstone Medical Packaging, Inc.
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and tr…
Olympus Corporation of the Americas
Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
Windstone Medical Packaging, Inc.
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Olympus Corporation of the Americas
Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C …
Windstone Medical Packaging, Inc.
EliA Sample Diluent, Article number, 83-1023-01
Phadia US 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.