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 · 2026-09-02
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 731 of 822
MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Strep A Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
Philips Medical Systems, Inc.
Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Draeger Medical Systems, Inc.
10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
EDDP Strip; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Cocaine Strip; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
THC Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
PCP Test (Strip); LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: …
Draeger Medical, Inc.
TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends the…
Technidata S.A.
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03…
Roche Diagnostics Operations, Inc.
Artis Zee Angiographic x-ray systems.
Siemens Medical Solutions USA, Inc
5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port,…
Teleflex Medical
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
RAYSEARCH LABORATORIES AB
10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device use…
Teleflex Medical
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic …
Allesee Orthodontic Appliances
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Merit Medical Systems, Inc.
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, u…
Draeger Medical Systems, Inc.
5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, ill…
Teleflex Medical
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: …
Stryker Howmedica Osteonics Corp.
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets…
Ormco/Sybronendo
Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Cata…
Teleflex Medical
Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the…
Merit Medical Systems, Inc.
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which hol…
Ormco/Sybronendo
5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and access…
Teleflex Medical
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Philips Medical Systems (Cleveland), Inc.
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immuno…
Siemens Medical Solutions Diagnostics
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assi…
Elekta, Inc.
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and …
Ethicon, Inc.
Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring.
Infantino LLC
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.