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 39 of 810
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
ICU Medical, Inc.
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
DAYE (ANNE'S DAY LTD)
ChemoLock Bag Spike, 01 units REF: CL-10-10
ICU Medical, Inc.
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OC…
Microgenics Corporation
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
IMPRIS Imaging Inc
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
ICU Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
ICU Medical, Inc.
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, …
ENDOMAGNETICS LTD
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
ICU Medical, Inc.
All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
DAYE (ANNE'S DAY LTD)
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
DAYE (ANNE'S DAY LTD)
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALIN…
Aesculap Inc
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALI…
Aesculap Inc
Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
DAYE (ANNE'S DAY LTD)
9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
DAYE (ANNE'S DAY LTD)
Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
DAYE (ANNE'S DAY LTD)
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…
Alcon Research LLC
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
CareFusion 303, Inc.
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138…
CareFusion 303, Inc.
Knog Recalls Bicycle Lights Due to Fire and Burn Hazards
The Kroger Co. Recalls Halloween-Themed Skeleton Wax Candles Due to Fire Hazard
The Kroger Co., of Cincinnati, Ohio
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medline Industries, LP
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
SEDECAL SA
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch…
Baxter Healthcare Corporation
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
SEDECAL SA
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 …
Cardinal Health 200, LLC
Model Number 40KWFXPLUS.004, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
SEDECAL SA
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
UIH Technologies LLC
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube,…
Cardinal Health 200, LLC
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, O…
CPM Medical Consultants, LLC.
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexc…
Tandem Diabetes Care, Inc.
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
SEDECAL SA
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
SEDECAL SA
SM_40HF_B_D_VIR3, Mobile X-ray system
SEDECAL SA
SM_40HF_BDC3, Mobile X-ray system
SEDECAL SA
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
SEDECAL SA
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump…
Cardinal Health 200, LLC
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray t…
Wipro GE Healthcare Private Ltd.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
UIH Technologies LLC
SHIMADZU RF.004, Mobile X-ray system
SEDECAL SA
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
UIH Technologies LLC
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
UIH Technologies LLC
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
SEDECAL SA
Model Number 40KW-FX.899, Mobile X-ray system
SEDECAL SA
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.