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 554 of 819
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
Windstone Medical Packaging, Inc.
Basin Pack, part number AMS2497
Windstone Medical Packaging, Inc.
Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A
Windstone Medical Packaging, Inc.
Hystero Pack, part number PSS3535(A
Windstone Medical Packaging, Inc.
Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D
Windstone Medical Packaging, Inc.
Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A
Windstone Medical Packaging, Inc.
Catheter Pack, part number AMS4399(A
Windstone Medical Packaging, Inc.
SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external batter…
MED-EL Elektromedizinische Gereate, Gmbh
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for int…
Cook Inc.
Lipo Pack, part AMS4420(A
Windstone Medical Packaging, Inc.
Ortho Minor Pack, part number AMS3710(A
Windstone Medical Packaging, Inc.
Lap/Pelviscopy Pack, part number PSS3256(B
Windstone Medical Packaging, Inc.
General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number AMS4798(A
Windstone Medical Packaging, Inc.
D & C Pack, part number AMS4796(A
Windstone Medical Packaging, Inc.
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access …
Cook Inc.
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 …
Maquet Datascope Corp - Cardiac Assist Division
General Plastic Pack, part number PSS2432(A
Windstone Medical Packaging, Inc.
Bleph Pack, part number AMS3325(B
Windstone Medical Packaging, Inc.
Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B
Windstone Medical Packaging, Inc.
Vein Tray, part number AMS6312
Windstone Medical Packaging, Inc.
Custom Pack - with Introducer Kit, part number TVS4011NI(L
Windstone Medical Packaging, Inc.
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
Windstone Medical Packaging, Inc.
Plastic Surgery Pack, part number AMS5685
Windstone Medical Packaging, Inc.
Head Pack, part number PSS1934(B
Windstone Medical Packaging, Inc.
Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PS…
Windstone Medical Packaging, Inc.
Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C …
Windstone Medical Packaging, Inc.
Total Joint Pack, part number 006358-6
Windstone Medical Packaging, Inc.
Custom Breast Augmentation Pack, part number PSS2455(D
Windstone Medical Packaging, Inc.
McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Mckesson Medical Imaging
GYN Lap Pack, part number PSS2194(B
Windstone Medical Packaging, Inc.
Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part …
Windstone Medical Packaging, Inc.
Peri GYN, part number PSS2193(A
Windstone Medical Packaging, Inc.
Set Up Pack, part number PSS3574(A
Windstone Medical Packaging, Inc.
Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B
Windstone Medical Packaging, Inc.
Basic Pack (1185), part number AMS6560
Windstone Medical Packaging, Inc.
Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
Windstone Medical Packaging, Inc.
Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number TVS4022(E Percutaneous Entry Kit, part number TVS4022(F
Windstone Medical Packaging, Inc.
Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B
Windstone Medical Packaging, Inc.
Plastic Kit, part number CMP1084(C
Windstone Medical Packaging, Inc.
Dr Bragg Vein Tray - RX, part number 007912-8
Windstone Medical Packaging, Inc.
Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E
Windstone Medical Packaging, Inc.
Facial Pack , part number AMS6501
Windstone Medical Packaging, Inc.
BD AffirM VPIII Microbial Identification Test
Becton Dickinson & Co.
Plastic General Pack, part number AMS4215
Windstone Medical Packaging, Inc.
Extremity Pack-N Brunswick, part number PSS1866(A
Windstone Medical Packaging, Inc.
Brow Pack, part number PSS1785(C
Windstone Medical Packaging, Inc.
Angio Pack, part number AMS6711
Windstone Medical Packaging, Inc.
Morris Lap Pack, part number PSS3199(A
Windstone Medical Packaging, Inc.
Universal Pack, part number AMS2036
Windstone Medical Packaging, Inc.
Facial Plastic Pack, part number AMS3327(C
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.