Reported Jul 24, 2019 · Ongoing

Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows:…

Medline Industries, Inc.

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, Inc. · 1170 S Northpoint Blvd · Waukegan, IL · 60085-6757

Is this the product you have?

  • Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits
  • Kit are labeled as followsROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPAROSCOPY CDS-LF, TRMC GENERAL ENDOSCOPY PACK, GENERAL ENDOSCOPIC PACK-LF, RVMC LAP CHOLE PACK, LAP CHOLE PACK, MH GENERAL LAPAROSCOPY, THORACIC, GB GENERAL ENDO, T & A, DM LAPAROSCOPY PACK, THORACIC ROBOT, LAVH PACK, LAPAROSCOPY, T AND A, SINUS PACK, ROBOTICS PACK-LF, GYN LAPAROSCOPY-LF, LAPAROSCOPIC PACK, GENERAL LAP PACK, ENT PACK, OPEN HEART PK A&B&C, LAPAROSCOPIC, LAP TUBAL LIGATION PACK, ROBOTICS SI, OPEN HEART CDS, LAPAROSCOPY CDS, LAP GASTRIC BY PASS, GENERAL LAPAROSCOPY PK-LF, THORACOTOMY THORACOSCOPY, T AND A COBLATOR, ROBOTICS PACK, TOTAL LAP HYSTERECTOMY CDS, LAPAROSCOPY TRAY-LF, PATEWOOD T AND A PACK, FESS PACK, AMB MSL W INJECTION, LAP CHOLE CDS, NASAL SEPTOPLASTY PACK, ENDOSCOPY PACK, AMB GYN LAPAROSCOPY, GASTRIC BYPASS CDS-LF, MHC LAP CHOLE, HHOR ENT, LAP BARIATRIC, LAPAROSCOPY PACK, MHC OPEN HEART 1 OF 2, BARIATRIC, GENERAL LAP PACK-LF, MAG LAPAROSCOPY CDS, SPRINGHILL LAP CHOLE PACK, BMHM GASTRIC BAND-BYPASS PACK, NASAL PACK, LAPAROSCOPY PACK - OSC, ALT GENERAL LAPAROSCOPY CDS, MER ROBOTIC, JAM/HRZ GENERAL LAPAROSCOPY, ARTHROSCOPY PACK, MAJOR LITHOTOMY SOMC-LF, BARI GASTRECTOMY CDS, LAP GYN PACK-LF, THORACOTOMY PACK-LF, T&A PACK-LF, PELVISCOPY PACK, GENERAL LAPAROSCOPY-LF, ROBOT GYN, MAJOR ENT PACK, TONSIL & ADENOIDS PACK, PROSTATE ROBOTIC, CARDIAC SURGERY CABG PACK-LF, LAP CHOLE TRAY, THORASCOPIC TETHERING OR PACK, ROBOTIC PACK, LAVH, OPEN HEART, LAP CHOLE QVH VER. B, BARIATRIC-LF, T&A TRAY #64-RF, BASIC LAP PACK W TUBING, TONSIL & ADENOID PACK, CUSTOM ENDOSCOPY PACK-LF, FESS TRAY #60-RF, LAP PACK WITHOUT TUBING, NASAL SINUS ENDOSCOPY, DAVINCI, TV LAP PACK-LF, MAD T & A, ROBOTIC GU/GYN, RICH LAVH, GYN ROBOTIC-LF, MAD GYN LAPAROSCOPY, PAD GYN LAPAROSCOPY, OSC GYN LAP, SUB GYN LAPAROSCOPY PACK-LF, LAPAROSCOPY-ROBOT, GYN LAP KIT, GENERAL LAP, LAP CHOLE PACK B10, LAP CHOLE CDS-LF, GYN LAPAROSCOPY PACK-LF, LAP CHOLE SURGICOUNT, DIAGNOSTIC LAP PACK, CABG-VEIN HARVESTING PACK-LF, TONSIL PACK UOPSC-LF, BELLEVUE T&A PACK, BGH 001471 SHOULDER PACK-LF, SCOPE LAP THOR PACK, MAIN/LAPAROSCOPY GYN PACK-LF, LAP CHOLE OR PACK, ENSEMBLE THORACO-LF, LAPAROSCOPIE CHIRURGICALE-LF, MAJOR GYN LAPAROSCOPY CDS, HEPATOBILIAIRE LAPAROSCOPIE-LF, GYNE MAJOR LAPAROSCOPY GRH-LF, LAP CHOLE PACK TBRHSC-LF, MAJOR LAPAROSCOPIC SJHC-LF, LAPAROSCOPY RVHS-LF, LAPAROSCOPY III-LF
Lot codes and dates
  • Fog solution Component Number80532/NONFB100B
  • Material Lot Number
    • 41186649M
    • 41186673M
    • 41211955M
    • 41186657M
    • 41236925M
    • 41186665M
    • 41102767M. Expiration Date 12/2020
  • Impacted Kit Number (Lot Number)

    233 of 233 codes

    • DYNJ902840B (19CBW843)
    • DYNJ904625B (19CBA697)
    • DYNJ42835A (19CBA118)
    • DYNJ39685A (19BBH495)
    • DYNJ32935C (19BBE174)
    • DYNJ36418F (19ABN461)
    • DYNJ50765B (19BBJ183)
    • DYNJ47704C (19BBE810)
    • DYNJ0862775N (19CBA813)
    • DYNJ43628A (19BBG651)
    • CDS984674C (19CBA033)
    • CDS984659K (19BBT877)
    • CDS984656L (19ABO984)
    • DYNJ0665310C (19CBG762)
    • DYNJ42547B (19BBI339)
    • DYNJ903659B (19BBT906)
    • DYNJ903040C (19BBS351)
    • DYNJ903038C (19CBB639)
    • DYNJ54065 (19BBJ372)
    • DYNJ900363G (19ABL752)
    • DYNJ57609 (19ABN755)
    • DYNJ903321J (19CBF179)
    • DYNJ900357K (19BBU012)
    • DYNJ904588 (19BBT976)
    • CDS920126Y (19ABI371)
    • DYNJ59847 (19ABN404)
    • DYNJ22661K (19BBF049)
    • DYNJ33545G (19ABI674)
    • DYNJ26209L (19BBG751)
    • DYNJ49882F (19ABN534)
    • DYNJ903014C (19BBU011)
    • CDS984155D (19BBD541)
    • DYNJ904638A (19ABZ742)
    • DYNJ59546 (19ABM642)
    • DYNJ903012B (19ABI127)
    • DYNJ43439B (19BBG181)
    • DYNJ904605B (19ABX225)
    • DYNJ902777C (19BBU748)
    • DYNJ45036C (19BBH070)
    • DYNJ0457880B (19BBD190)
    • CDS760059F (19CBS256)
    • DYNJ52677G (19ABM568)
    • DYNJ37208B (19ABN372)
    • DYNJ57108 (19BBH759)
    • DYNJ27981L (19BBU534)
    • DYNJ22708C (19CBI729)
    • DYNJ42513B (19BBC527)
    • DYNJ902659D (19DBC026)
    • CDS984368A (19CBS618)
    • CDS985100G (19BBU591)
    • DYNJ902881A (19BBU615)
    • DYNJ36733B (19BBT315)
    • DYNJ902882B (19BBQ157)
    • DYNJ56866A (19BBJ416)
    • DYNJ43971 (19ABO971)
    • CDS983055I (19BBD510)
    • DYNJ24254D (19ABE952)
    • DYNJ51727A (19BBJ776)
    • DYNJ43160 (19BBE200)
    • DYNJ59927 (19ABM565)
Amount recalled
14,550 units

Where it was sold

Why it was recalled

The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Medline Industries, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.