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 · 2026-09-01
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 694 of 822
O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wound…
Customed, Inc
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Ethicon, Inc.
Breast Pack Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Customed, Inc
Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient care procedures such as wound healing, suture removals, ir…
Customed, Inc
Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, i…
Customed, Inc
Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irriga…
Customed, Inc
Premium Laparotomy Pack, Catalog number 900-1296. Used by medical staff to perform patient care procedures such as wound healing, suture removals,…
Customed, Inc
Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient care procedures such as wound healing, suture removals, ir…
Customed, Inc
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended fo…
Gambro Renal Products Inc
Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wound…
Customed, Inc
Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform patient care procedures such as wound healing, suture remova…
Customed, Inc
Tummy Tuck Pack, Catalog #900-3026 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wound…
Customed, Inc
Arthroscopy Pack, Catalog number 900-620. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
Customed, Inc
Universal Pack, Catalog number 900-1936. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
Customed, Inc
Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
Customed, Inc
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within t…
CooperSurgical, Inc.
Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals,…
Customed, Inc
Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wound…
Customed, Inc
Cysto Tur Pack, Catalog number 900-080. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate …
Customed, Inc
McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: …
Aircraft Medical Limited
Angiography Pack, catalog #900-210 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wound…
Customed, Inc
Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
Customed, Inc
Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture remov…
Customed, Inc
Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irr…
Customed, Inc
Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
Customed, Inc
Arthroscopy Pack, catalog #900-2473 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate woun…
Customed, Inc
Amerigel Post-op Surgical Kits Wound management
Amerx Health Care Corp.
Laparoscopy OB GYN Pack, Catalog number 900-1192. Used by medical staff to perform patient care procedures such as wound healing, suture removals,…
Customed, Inc
Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, …
Customed, Inc
Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical staff to perform patient care procedures such as wound healing, suture…
Customed, Inc
General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wo…
Customed, Inc
Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by medical staff to perform patient care procedures such as wound …
Customed, Inc
Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform patient care procedures such as wound healing, suture removals, i…
Customed, Inc
Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
Customed, Inc
Ophtalmic Pack, Catalog number 900-1780. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
Customed, Inc
Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, sutur…
Customed, Inc
Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate w…
Customed, Inc
Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to perform patient care procedures such as wound healing, suture …
Customed, Inc
Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
Customed, Inc
C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…
Customed, Inc
Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro)…
Beevers Manufacturing & Supply, Inc.
Dressing Change, Catalog number 900-1538. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
Customed, Inc
Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irri…
Customed, Inc
Urology Pack, Catalog number 900-1738. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate w…
Customed, Inc
Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate …
Customed, Inc
Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, …
Customed, Inc
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator …
Integra LifeSciences Corp.
Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irri…
Customed, Inc
Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, et…
Customed, Inc
O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wound…
Customed, 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.