Reported May 13, 2026 · Ongoing
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
22 of 22 products
| Model / number | Product as published |
|---|---|
CDS981504G | GYN LAPAROSCOPY CDS |
CDS982407P | BAP NORTH ROBOTIC SURGERY CDS |
CDS982893I | ROBOTIC GYN CDS-1 |
CDS983300J | GYN LAPAROSCOPY CDS |
CDS984243G | NHP ROBOTIC GYNE CDS |
CDS984543D | ROBOTIC-LF |
CDS984543F | ROBOTIC-LF |
CDS984543G | ROBOTIC-LF |
CDS984543I | ROBOTIC-LF |
CDS984860F | GYN CDS |
CDS985423G | GYN LAP PELVI |
DYKM1657A | GYN KIT |
DYKMBNDL100 | KIT GYN ONCOLOGY LAP |
DYKMBNDL109 | KIT ROBOTICS GYN |
DYKMBNDL116D | KIT ROBOTICS UROLOGY PROSTATE |
DYKMBNDL116F | KIT ROBOTICS UROLOGY PROSTATE |
DYKMBNDL119 | KIT GYN VAGINAL MAJOR |
DYKMBNDL119A | KIT GYN VAGINAL MAJOR |
DYKMBNDL168 | KIT GYN ABDOMINAL MAJOR |
DYKMBNDL168A | KIT GYN ABDOMINAL MAJOR |
- Lot codes and dates
357 of 357 products
Products covered by this recall # Barcodes Product as published 1 1019532711011640195327110117Lot Number: 25BDB744; 2) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case) 2 1019532711011640195327110117Lot Number: 23EBE997; 3) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case) 3 1019532711011640195327110117Lot Number: 23GBL921; 4) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case) 4 1019532711011640195327110117Lot Number: 23GBO574; 5) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case) 5 1019532711011640195327110117Lot Number: 23IBC607; 6) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case) 6 1088994220805040889942208051Lot Number: 23JBQ095; 7) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case) 7 1019348942504840193489425049Lot Number: 24IBO240; 8) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case) 8 1019348987252140193489872522Lot Number: 21CDB781; 9) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 9 1019348987252140193489872522Lot Number: 21EBA117; 10) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 10 1019348987252140193489872522Lot Number: 21GBI171; 11) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 11 1019348987252140193489872522Lot Number: 21HBN807; 12) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 12 1019348987252140193489872522Lot Number: 21IBM804; 13) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 13 1019348987252140193489872522Lot Number: 21VBA272; 14) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 14 1019348987252140193489872522Lot Number: 22BBL450; 15) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 15 1019348987252140193489872522Lot Number: 22FBV462; 16) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 16 1019348987252140193489872522Lot Number: 22GBP114; 17) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 17 1019348987252140193489872522Lot Number: 22HBV491; 18) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 18 1019348987252140193489872522Lot Number: 22JBC547; 19) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 19 1019348987252140193489872522Lot Number: 22KBD152; 20) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) 20 1019348987252140193489872522Lot Number: 22OBM422; 21) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case) - Amount recalled
- 15806 units
This recall covers 42 products
The agency filed one notice per product. You are reading one of them; the other 41 are below.
29 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
This product could cause temporary or reversible health problems — stop using it.
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