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
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 216 of 819
PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
Biomerieux Inc
API JAMES 2AMP, CATALOG 70542
Biomerieux Inc
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
Biomerieux Inc
VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
Biomerieux Inc
VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
Biomerieux Inc
ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
Biomerieux Inc
VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
Biomerieux Inc
ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
Biomerieux Inc
PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
Biomerieux Inc
PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
Biomerieux Inc
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
Biomerieux Inc
BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017
Biomerieux Inc
ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333
Biomerieux Inc
ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
Biomerieux Inc
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay syste…
Randox Laboratories Ltd.
ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
Biomerieux Inc
VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
Biomerieux Inc
PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
Biomerieux Inc
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
Biomerieux Inc
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
Biomerieux Inc
VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
Biomerieux Inc
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
Biomerieux Inc
VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
Biomerieux Inc
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum a…
Ortho-Clinical Diagnostics, Inc.
VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
Biomerieux Inc
VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
Biomerieux Inc
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
Biomerieux Inc
VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and …
Steris Corporation
ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445
Biomerieux Inc
VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404
Biomerieux Inc
DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
Biomerieux Inc
API 20 E 25 STRIPS, CATALOG 20100
Biomerieux Inc
9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
ENDO Pharmaceuticals Solutions, Inc.
VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
Biomerieux Inc
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine moni…
Steris Corporation
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
Biomerieux Inc
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Remington Medical, Inc.
Pilling Wecksorb Cylindrical Sponges
TELEFLEX LLC
Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ -…
Acumed LLC
Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Sc…
Acumed LLC
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acut…
Acumed LLC
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm …
Acumed LLC
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Young Dental Manufacturing I, LLC
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Baxter Healthcare Corporation
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Icotec Ag
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Baxter Healthcare Corporation
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Howmedica Osteonics Corp.
HeartWare Model 1100
Heartware, Inc.
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid…
GE Medical Systems, LLC
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
ConvaTec, 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.