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 38 of 810
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collec…
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT0911…
BALT USA, LLC
ICU Medical ChemoLock Port REF: CL2100
ICU Medical, Inc.
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated…
ICU Medical, Inc.
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
ICU Medical, Inc.
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…
Alcon Research LLC
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
ICU Medical, Inc.
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
DAYE (ANNE'S DAY LTD)
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer R…
ICU Medical, Inc.
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
PHILIPS MEDICAL SYSTEMS
ICU Medical ChemoLock Bag Spike REF: CL-10
ICU Medical, Inc.
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
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
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Theater Inc
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
DAYE (ANNE'S DAY LTD)
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
ICU Medical, Inc.
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Sof…
Dexcom, Inc.
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
DAYE (ANNE'S DAY LTD)
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
DAYE (ANNE'S DAY LTD)
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
CareFusion 303, Inc.
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
ICU Medical, Inc.
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
MicroSurgical Technology Inc
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
DAYE (ANNE'S DAY LTD)
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
DAYE (ANNE'S DAY LTD)
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Fresenius Kabi USA, LLC
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Theater Inc
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
ICU Medical, Inc.
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
ICU Medical, Inc.
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
DAYE (ANNE'S DAY LTD)
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
ICU Medical, Inc.
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
ICU Medical, Inc.
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
DAYE (ANNE'S DAY LTD)
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
ICU Medical, Inc.
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
IMPRIS Imaging Inc
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Greiner Bio-One North America, Inc.
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
DAYE (ANNE'S DAY LTD)
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagen…
Cepheid
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
DAYE (ANNE'S DAY LTD)
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Surgical Theater Inc
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
ICU Medical, Inc.
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented…
ICU Medical, Inc.
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
DAYE (ANNE'S DAY LTD)
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
ICU Medical, Inc.
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
DAYE (ANNE'S DAY LTD)
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), a…
Vantive US Healthcare LLC
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
DAYE (ANNE'S DAY LTD)
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
ICU Medical, Inc.
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…
Alcon Research LLC
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Siemens Healthcare Diagnostics, Inc.
Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
DAYE (ANNE'S DAY LTD)
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.