FDA Devices recall · Reported July 24, 2019
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 N
The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.
Medline Industries, Inc. recalled Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit… - a moderate-severity action.
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit… was recalled by Medline Industries, Inc. in July 24, 2019. Reason: The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.. Check the official notice for the remedy. Verify recall #Z-1984-2019 with the FDA Devices before acting.
The recall
Medline Industries, Inc. issued this moderate-severity FDA Devices recall-The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties..
- Moderate
- severity level
- 15K units
- affected scope
- Class II
- classification
- July 24, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1984-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Reason for recall
The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1984-2019 |
| Date reported | July 24, 2019 |
| Date initiated | May 30, 2019 |
| Recalling firm | Medline Industries, Inc. |
| Firm location | Waukegan, IL |
| Affected scope | 14,550 units |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1984-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026