PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
total recalls
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 142 of 808

FDA Devices Critical Mar 6, 2024

MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 6, 2024

Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instru…

Medagent Inc

FDA Devices Critical Mar 6, 2024

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid …

Medtronic Neurosurgery

FDA Devices Moderate Mar 6, 2024

GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF…

GRAPHENANO DENTAL SL

FDA Devices Critical Mar 6, 2024

MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE18…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TR…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESS…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005

Vyaire Medical

FDA Devices Critical Mar 6, 2024

MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCO…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 6, 2024

Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Integra LifeSciences Corp.

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHAN…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 6, 2024

Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Integra LifeSciences Corp.

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number PCF-H180AL.

Olympus Corporation of the Americas

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number CF-HQ190L.

Olympus Corporation of the Americas

FDA Devices Critical Mar 6, 2024

Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2

Vyaire Medical

FDA Devices Critical Mar 6, 2024

MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSE…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW K…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 6, 2024

Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Integra LifeSciences Corp.

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F

Vyaire Medical

FDA Devices Critical Mar 6, 2024

MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid…

Medtronic Neurosurgery

FDA Devices Moderate Mar 6, 2024

Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Integra LifeSciences Corp.

FDA Devices Moderate Mar 6, 2024

Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.

EMD Millipore Corporation

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 6, 2024

Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plat…

Acumed LLC

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number PCF-Q180AL.

Olympus Corporation of the Americas

FDA Devices Moderate Mar 6, 2024

Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.

Integra LifeSciences Corp.

FDA Devices Critical Mar 6, 2024

AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2

Vyaire Medical

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND4…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CAR…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 6, 2024

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient u…

Zyno Medical LLC

FDA Devices Moderate Mar 6, 2024

USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125,…

United Orthopedic Corporation

FDA Devices Low Mar 6, 2024

Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

Abbott Molecular, Inc.

FDA Devices Critical Mar 6, 2024

Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 6, 2024

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cer…

Medtronic Neurosurgery

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number CF-HQ190I.

Olympus Corporation of the Americas

FDA Devices Critical Mar 6, 2024

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001

Vyaire Medical

FDA Devices Critical Mar 6, 2024

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,

Vyaire Medical

FDA Devices Moderate Mar 6, 2024

Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.

Parker Laboratories, Inc.

FDA Devices Low Mar 6, 2024

In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Pro…

Abbott Molecular, Inc.

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number PCF-HQ190L.

Olympus Corporation of the Americas

FDA Devices Critical Mar 6, 2024

Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360

MEDLINE INDUSTRIES, LP - Northfield

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

Category data as of Jul 2, 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 2, 2026.