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 · 2026-09-03
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 763 of 822
SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
Sarken, Inc.
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fract…
Synthes USA HQ, Inc.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkha…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product …
Megadyne Medical Products, Inc.
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: …
Ventana Medical Systems Inc
HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical…
Life Technologies Corporation
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data …
GE Healthcare, LLC
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkha…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, …
Medtronic Inc. Cardiac Rhythm Disease Management
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkha…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of fl…
Siemens Healthcare Diagnostics
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Roche Diagnostics Operations, Inc.
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
Becton Dickinson & Co.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkha…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total…
Stryker Howmedica Osteonics Corp.
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm …
Remel Inc
Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) H…
Stryker Craniomaxillofacial Division
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhau…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
Sarken, Inc.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhau…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear acc…
Brainlab AG
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhau…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkha…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
Philips Healthcare Inc.
OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store a…
Celera Corporation
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purp…
GE Healthcare, LLC
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Syst…
Siemens Healthcare Diagnostics
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and old…
Micro Therapeutics Inc, Dba Ev3 Neurovascular
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
Becton Dickinson & Co.
SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
Sarken, Inc.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhau…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
Sarken, Inc.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Bark…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) …
DeRoyal Industries Inc
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (13…
Zimmer, Inc.
SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in s…
SpineNet
PrepStain AG. For use in the screening and detection of cervical cancer.
Becton Dickinson & Co.
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Respironics California Inc
Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Pro…
Stryker Howmedica Osteonics Corp.
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
Siemens Medical Solutions USA, Inc
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Bark…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhaus…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be…
Zimmer, Inc.
Synthes Trauma Nail System. The devices are indication for bone fixation.
Synthes USA HQ, Inc.
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Produc…
Zimmer, Inc.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhau…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkha…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkha…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/1…
Zimmer, Inc.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkha…
Waldemar Link GmbH & Co. KG (Corp. Hq.)
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.