CLASS II ONGOING Device recall · Reported 24 Jul 2019 · FDA Enforcement Report
Anti-fog solution recalled by Medline Industries
Medline Industries is recalling Anti-fog solution, distributed nationwide in the US. The recall was initiated on 30 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1984-2019
- FDA event ID
- 83000
- Recalling firm
- Medline Industries, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 May 2019
- FDA classified
- 18 Jul 2019
- Reported
- 24 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 30 May 2019 | Recall initiated by company | |
| 18 Jul 2019 | Classified by FDA | +49 days |
| 24 Jul 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC 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.
Where it was distributed
Nationwide distribution to AL, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, WY. Worldwide distribution to Canada and Malaysia.
Nationwide AlabamaArkansasCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMaineMichiganMissouriMississippi
Questions about this recall
Is Anti-fog solution recalled?
Yes. Medline Industries recalled Anti-fog solution on 30 May 2019. The recall is Class II and its status is Ongoing. Recall number Z-1984-2019.
Why was it recalled?
The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.
Which lots are affected?
Fog solution Component Number: 80532/NONFB100B, Material Lot Number: 41186649M, 41186673M, 41211955M, 41186657M, 41236925M, 41186665M, 41102767M. Expiration Date 12/2020. Impacted Kit Number (Lot Number): 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), CDS985356F (19CBH288), DYNJ50960D (19BBG937), DYNJ50594B (19BBC092), DYNJ59925 (19ABI682), CDS983771F (19BBS841), DYNJ903722F (19CBC482), DYNJ903688D (19BBN377), DYNJ901777M (19CBB415), DYNJ56696A (19BBT371), DYNJ904790B (19CBC724), DYNJ904826 (19BBA006), PHS628590008A (19BBG657), CDS982906K (19CBE109), DYNJ40736D (19ABE199), DYNJ32364F (19BBO433), DYNJ56626A (19BBI464), DYNJ43573A (19BBE169), CDS983900G (19CBE065), DYNJ901430F (19CBV052), DYNJ900760J (19CBA299), DYNJ36365B (19BBB942), DYNJ901160D (19ABH656), CDS860237V (19CBL702), DYNJ0618440D (19ABH894), DYNJ50543A (19ABI681), DYNJ0798129F (19BBD878), DYNJ31754C (19BBT585), DYNJ900723A (19DBF086), DYNJ900299D (19CBB300), DYNJ45576A (19BBU372), DYNJ53270B (19BBT500), DYNJ901822 (19BBA013), DYNJ24608F (19BBQ880), DYNJ41082F (19ABN865), DYNJ51144A (19ABM266), DYNJ50474B (19ABM212), DYNJ900298F (19CBD978), CDS981161W (19CBC564), DYNJ903906B (19CBM352), DYNJ904214A (19CBB908), DYNJ27440R (19BBG783), DYNJ57093 (19ABM639), DYNJ43427C (19ABM274), DYNJ55478B (19BBS313), DYNJ27430P (19BBE005), DYNJ53718A (19BBG277), DYNJ54690A (19BBC770), DYNJ901076F (19BBU036), DYNJ41531F (19BBJ347), DYNJ902165C (19BBR800), CDS983393I (19CBF160), DYNJ902188G (19ABY723), DYNJ903000D (19BBP501), DYNJ902172C (19ABL727), DYNJ902136F (19CBD684), DYNJ901868B (19BBU852), DYNJ30799D (19ABN506), DYNJ905003A (19CBK506), DYNJ56110 (19BBR129), DYNJ52016 (19BBU234), DYNJ57571 (19CBA099), CDS982234F (19ABZ502), DYNJ01910I (19ABU373), DYNJ45531C (19BBD198), DYNJ40156B (19CBA412), DYNJ20431K (19BBI165), DYNJ39810B (19ABI411), DYNJ35833C (19BBG604), DYNJ0705925D (19BBJ785), DYNJ00210K (19BBG066), DYNJ0567019U (19ABN489), DYNJ42420A (19ABO947), DYNJ48752A (19BBQ917), DYNJ58542A (19BBT963), CDS984007B (19BBR816), DYNJ47554B (19ABN648), DYNJ41789C (19ABN541), DYNJ41939A (19BBG785), DYNJ900787C (19CBS603), DYNJ46864 (19BBU487), DYNJS3024 (19ABL847), DYNJQ9044M (19BBS346), DYNJ33112G (19BBS717), DYNJ901674F (19BBS864), CDS984659K (19CBI752), DYNJ57609 (19CBA524), DYNJ905095 (19BBF351), DYNJ40064I (19BBF021), DYNJ905797 (19ABZ654), CDS981512D (19CBL323), DYNJ53067C (19ABA014), CDS985242D (19BBT180), DYNJ901501C (19BBI586), DYNJ901501C (19BBU616), DYNJ37208B (19BBG261), DYNJ60647 (19ABN834), DYNJ48601 (19BBG158), DYNJ57623 (19BBG755), DYNJ50746 (19ABM536), DYNJ48599 (19BBG561), DYNJ903514B (19CBA001), CDS983055I (19CBL202), DYNJ24254D (19CBA271), DYNJ50958C (19BBE201), DYNJQ0589J (19ABI633), DYNJQ0589J (19BBG274), DYNJ30954 (19ABR748), DYNJ33197G (19ABH728), DYNJ33197G (19BBI455), DYNJ902830B (19BBS834), DYNJ53409 (19BBI406), DYNJ53409 (18MB7934), DYNJ46488C (19BBC858), DYNJ56036A (19BBG377), DYNJ902250C (19BBS839), DYNJ904826 (19BBN793), DYNJ904826 (19BBR431), CDS982906K (19CBI565), DYNJ902546G (19ABX896), DYNJ48431B (19ABJ347), DYNJ901210D (19CBK476), DYNJ901210D (19EBB837), DYNJ30988C (19ABN378), DYNJ30988C (19BBT617), DYNJ41365D (19BBG190), DYNJ39406A (19ABN416), DYNJ56004 (19CBA327), DYNJ901160D (19BBS792), DYNJ50052A (19BBJ218), DYNJ60067 (19BBG907), DYNJ903254A (19BBD540), DYNJ903254A (19CBG054), CDS981537D (19CBA526), DYNJ49351 (19BBJ114), DYNJ40981F (19BBG606), DYNJ43869I (19ABE918), DYNJ33189 (19BBE839), DYNJ46962F (19CBA778), DYNJ53650B (19ABJ753), DYNJ02309C (19BBG760), DYNJ49558B (19BBB744), DYNJ39666D (19BBI360), DYNJ55323B (19BBQ851), DYNJ901330C (19ABX749), DYNJ51195C (19ABM930), DYNJ41630B (19BBG910), CDS984769D (19CBM279), DYNJ902188G (19CBR545), DYNJ902188G (19DBM497), DYNJ39458G (19ABO674), DYNJ45498A (19ABM460), DYNJ35671A (19ABM918), DYNJ39304B (19ABO289), DYNJ54966 (19BBB884), DYNJ57583 (19BBG432), DYNJ53992A (19BBC971), CDS985035I (19CBB959), DYNJ01910I (19BBG799), DYNJ45664A (19BBG315), DYNJ45806C (19ABN758), DYNJ42117 (19CBA827), DYNJ21888N (19BBE998), DYNJ37358D (19BBT664), DYNJ56957B (19BBF044), DYNJ54675A (18LBM107), DYNJ52468 (18KBR226), CDS985025C (19BBE399), CDS985025C (19CBA021), SYNJ10073C (19BBE680), DYNJ20431K (19CBA470), CDS983989C (19BBM834), DYNJ900787C (19BBF368), DYNJHTLP01 (19BBC630).
Where was it sold?
Nationwide distribution to AL, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, WY. Worldwide distribution to Canada and Malaysia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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