Reported Aug 9, 2023 · Ongoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following
MEDLINE INDUSTRIES, LP - Northfield
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 - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following
18 of 18 products
| Model / number | Product as published |
|---|---|
DYNJ902540N | CHN OR DAVINCI PROSTATE |
DYNJ63257B | CUSTOM GYN |
DYNJ0771979C | DBD-AMNIOCENTESIS PACK-LF |
DYNJ906578F | DBD-GYN EXP LAPAROTOMY |
DYNJ906579F | DBD-GYN LITHOTOMY |
DYNJ906616G | DBD-GYN LS |
DYNJ905824I | DBD-ROBOTICS GYN |
DYNJ906578D | GYN EXP LAPAROTOMY |
DYNJ906579A | GYN LITHOTOMY, , DYNJ906579B, DYNJ906579D, DYNJ906579F |
DYNJ906616A | GYN LS, , DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F |
DYNJ0752001K | GYN ROBOTIC CUSTOM PACK-LF |
DYNJ904343D | ROBOTIC, , DYNJ904343F |
DYNJ60009B | ROBOTIC GYN SSC, , DYNJ60009C |
DYNJ904250G | ROBOTIC PACK-LF |
DYNJ905826G | ROBOTIC PROSTATECTOMY |
DYNJ904254G | ROBOTIC-LF, , DYNJ904254I |
DYNJ905824F | ROBOTICS GYN, , DYNJ905824G, DYNJ905824I |
DYNJ64027A | SSC GU ROBOTIC PACK, , DYNJ64027B |
- Amount recalled
- 7,462 kits
This recall covers 50 products
The agency filed one notice per product. You are reading one of them; the other 49 are below.
37 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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