Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 62 of 810
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
BioFire Diagnostics, LLC
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120…
Onkos Surgical, Inc.
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Maquet Cardiopulmonary Ag
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Cardinal Health 200, LLC
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Ultra Clean Systems, Inc.
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Siemens Healthcare Diagnostics, Inc.
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Mckesson Medical-Surgical Inc. Corporate Office
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438…
Baxter Healthcare Corporation
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Mckesson Medical-Surgical Inc. Corporate Office
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Cardinal Health 200, LLC
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Siemens Healthcare Diagnostics, Inc.
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (S…
C-RAD POSITIONING AB
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Cardinal Health 200, LLC
ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
GM Helix Acqua Implant, Article Number: 140.984
Straumann USA LLC
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
NxStage Medical Inc
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Cardinal Health 200, LLC
ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Cardinal Health 200, LLC
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Mckesson Medical-Surgical Inc. Corporate Office
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Cardinal Health 200, LLC
ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Mckesson Medical-Surgical Inc. Corporate Office
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Onkos Surgical, Inc.
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Onkos Surgical, Inc.
ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Mckesson Medical-Surgical Inc. Corporate Office
Plus Initial Drill, Article Number: 103.170;
Straumann USA LLC
GM Helix Acqua Implant, Article Number: 140.985
Straumann USA LLC
ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SAL…
Onkos Surgical, Inc.
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
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 Jun 3, 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 Jun 3, 2026.