PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported May 27, 2020

Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS

Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.

Recall #
Z-2040-2020
Affected scope
92,902 kits
Initiated
March 9, 2020
Compiled from official public sources by the publisher.
Verify with FDA Devices →
View my saved recalls

Medline Industries Inc recalled Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sp… - a moderate-severity action.

Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sp… was recalled by Medline Industries Inc in May 27, 2020. Reason: Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the…. Check the official notice for the remedy. Verify recall #Z-2040-2020 with the FDA Devices before acting.

The recall

Medline Industries Inc issued this moderate-severity FDA Devices recall-Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the….

Moderate
severity level
Class II
classification
May 27, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2040-2020 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

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

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

Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DYNJ0619768D CARDIAC PROCEDURE PACK DYNJ63700 CLOSURE CDS CDS983704D CLOSURE CDS CDS983704F CLOSURE CDS CDS983704G COLECTOMY LAPAROSCOPIC DYNJ906875 COLORECTAL ME DYNJ906437 CRANIOTOMY DYNJ905330A CRANIOTOMY DYNJ905330B C-SECTION PACK DYNJ32884F C-SECTION PACK DYNJ32884G C-SECTION PACK DYNJ32884I C-SECTION PACK DYNJ32884J C-SECTION TRAY DYNJ62707 CYSTO DYNJ901329B CYSTO DYNJ901608B CYSTO DYNJ903225I CYSTO CDS982015O CYSTO DYNJ903225J CYSTO CDS982015P CYSTO DYNJ903225K CYSTO DYNJ906481 CYSTO DYNJ903225L CYSTO CDS CDS985376C CYSTO CDS-LF CDS982481I CYSTO CDS-LF CDS982481J CYSTO CDS-LF CDS982481K CYSTO CDS-LF CDS982481L CYSTO PACK DYNJ05177G CYSTO PACK DYNJ51350A CYSTO PACK DYNJ37252F CYSTO PACK DYNJV0052L CYSTO PACK DYNJ37680D CYSTO PACK DYNJ58223 CYSTO PACK DYNJ53570A CYSTO PACK CMPJ01845I CYSTO PACK DYNJ37252G CYSTO PACK DYNJ37252I CYSTO PACK-LF DYNJ24911D CYSTO PACK-LF CMPJ02168J CYSTO PACK-LF DYNJ30470B CYSTO PACK-LF CMPJ02168K CYSTO PACK-LF DYNJ51350B CYSTO PACK-LF DYNJ51350C CYSTO TRAY-LF DYNJ42146A CYSTO/UROLOGY PACK DYNJ64197 CYSTO-LF DYNJ50098 CYSTOSCOPY-LF DYNJ22891I D&C HYSTEROSCOPY DYNJ901049B D&C HYSTEROSCOPY DYNJ901049C D&C HYSTEROSCOPY DYNJ901049D D&C HYSTEROSCOPY PACK CMPJ43148C D&C HYSTEROSCOPY PACK CMPJ43148D D&C HYSTEROSCOPY PACK CMPJ43148F D&C PACK DYNJ33603D D&C PACK DYNJ22567C D&C PACK DYNJ22567D D&C PACK DYNJ55814B D&C PACK-LF DYNJ22567F D&C/GYN-LF DYNJ61949 D&C/GYN-LF DYNJ61949A D&C-LF DYNJ50099A D&C-LF DYNJ906482 DELIVERY PACK SMMC-LF DYNJ35244D DELIVERY PACK SMMC-LF DYNJ35244F DENTAL ENT PACK-LF DYNJ43405B DR H PACK DYNJ62374 DR. S PACK DYNJ60499 EAR DYNJ906058A EAR DYNJ906058B EAR DYNJ906058F GEN PLASTIC DYNJ901298A GENERAL DELIVERY PACK-LF DYNJ15915F GENERAL PACK DYNJ37894B GENERAL PACK DYNJ61784 G S CYSTO PACK DYNJ62403 G CYSTO CDS CDS984190G G CYSTO CDS CDS984190I G CYSTO CDS CDS984190J G D & C CDS CDS984203F G D & C CDS CDS984203G G D & C CDS CDS984203I G D & C CDS CDS984203J G LASER VEIN CDS CDS984193M G LASER VEIN CDS CDS984193N G PELVISCOPY CDS CDS984187M G PELVISCOPY CDS CDS984187N G PELVISCOPY CDS CDS984187O G PELVISCOPY CDS CDS984187P G VAGINAL CDS CDS984201M G VAGINAL CDS CDS984201O G VAGINAL CDS CDS984201P G VAGINAL CDS CDS984201Q GU SEED PACK-RF-LF DYNJ01631F GU-GEN ROBOTIC PACK CMPJ11121 GYN LAPAROSCOPY DYNJ903869 GYN LAPAROSCOPY DYNJ901636B GYN LAPAROSCOPY DYNJ902101A GYN LAPAROSCOPY DYNJ37256D GYN LAPAROSCOPY DYNJ903869A GYN LAPAROSCOPY DYNJ903869B GYN LAPAROSCOPY DYNJ903869C GYN LAPAROSCOPY DYNJ903869D GYN LAPAROSCOPY CDS CDS983410C GYN LAPAROSCOPY CDS CDS985217D GYN LAPAROSCOPY CDS CDS983410D GYN LAPAROSCOPY CDS CDS985217F GYN LAPAROSCOPY CDS CDS983410F GYN LAPAROSCOPY CDS CDS985217G GYN LAPAROSCOPY PACK DYNJ48614C GYN LAPAROSCOPY PACK DYNJ22568F GYN LAPAROSCOPY PACK DYNJ22568G GYN LAPAROSCOPY PACK DYNJ37337G GYN LAPAROSCOPY PACK-LF DYNJ22568I GYN LAPAROSCOPY/LAVH CDS CDS981294C GYN LITHOTOMY PACK DYNJ48615B GYN ONCOLOGY ME DYNJ900201G GYN ROBOTIC DYNJ903282D GYN ROBOTIC DYNJ903282F GYN ROBOTIC DYNJ903282G GYN ROBOTIC DYNJ903282I GYN ROBOTIC DYNJ903282J GYN ROBOTIC DYNJ903282L GYN-URO LAPAROSCOPY DYNJ904856 GYN-URO LAPAROSCOPY DYNJ904856A HEAD AND NECK PACK DYNJ46509C HEART PACK A&B CMPJ22236V HH PAIN CLINIC PACK DYNJ59488 HMT CY

Reason for recall

Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2040-2020
Date reported May 27, 2020
Date initiated March 9, 2020
Recalling firm Medline Industries Inc
Firm location Northfield, IL
Affected scope 92,902 kits
Distribution nationwide

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-2040-2020) 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.

Frequently Asked Questions

What product was recalled? ▼
Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DYNJ0619768D CARDIAC PROCEDURE PACK DYNJ63700 CLOSURE CDS CDS983704D CLOSURE CDS CDS983704F CLOSURE CDS CDS983704G COLECTOMY LAPAROSCOPIC DYNJ906875 COLORECTAL ME DYNJ906437 CRANIOTOMY DYNJ905330A CRANIOTOMY DYNJ905330B C-SECTION PACK DYNJ32884F C-SECTION PACK DYNJ32884G C-SECTION PACK DYNJ32884I C-SECTION PACK DYNJ32884J C-SECTION TRAY DYNJ62707 CYSTO DYNJ901329B CYSTO DYNJ901608B CYSTO DYNJ903225I CYSTO CDS982015O CYSTO DYNJ903225J CYSTO CDS982015P CYSTO DYNJ903225K CYSTO DYNJ906481 CYSTO DYNJ903225L CYSTO CDS CDS985376C CYSTO CDS-LF CDS982481I CYSTO CDS-LF CDS982481J CYSTO CDS-LF CDS982481K CYSTO CDS-LF CDS982481L CYSTO PACK DYNJ05177G CYSTO PACK DYNJ51350A CYSTO PACK DYNJ37252F CYSTO PACK DYNJV0052L CYSTO PACK DYNJ37680D CYSTO PACK DYNJ58223 CYSTO PACK DYNJ53570A CYSTO PACK CMPJ01845I CYSTO PACK DYNJ37252G CYSTO PACK DYNJ37252I CYSTO PACK-LF DYNJ24911D CYSTO PACK-LF CMPJ02168J CYSTO PACK-LF DYNJ30470B CYSTO PACK-LF CMPJ02168K CYSTO PACK-LF DYNJ51350B CYSTO PACK-LF DYNJ51350C CYSTO TRAY-LF DYNJ42146A CYSTO/UROLOGY PACK DYNJ64197 CYSTO-LF DYNJ50098 CYSTOSCOPY-LF DYNJ22891I D&C HYSTEROSCOPY DYNJ901049B D&C HYSTEROSCOPY DYNJ901049C D&C HYSTEROSCOPY DYNJ901049D D&C HYSTEROSCOPY PACK CMPJ43148C D&C HYSTEROSCOPY PACK CMPJ43148D D&C HYSTEROSCOPY PACK CMPJ43148F D&C PACK DYNJ33603D D&C PACK DYNJ22567C D&C PACK DYNJ22567D D&C PACK DYNJ55814B D&C PACK-LF DYNJ22567F D&C/GYN-LF DYNJ61949 D&C/GYN-LF DYNJ61949A D&C-LF DYNJ50099A D&C-LF DYNJ906482 DELIVERY PACK SMMC-LF DYNJ35244D DELIVERY PACK SMMC-LF DYNJ35244F DENTAL ENT PACK-LF DYNJ43405B DR H PACK DYNJ62374 DR. S PACK DYNJ60499 EAR DYNJ906058A EAR DYNJ906058B EAR DYNJ906058F GEN PLASTIC DYNJ901298A GENERAL DELIVERY PACK-LF DYNJ15915F GENERAL PACK DYNJ37894B GENERAL PACK DYNJ61784 G S CYSTO PACK DYNJ62403 G CYSTO CDS CDS984190G G CYSTO CDS CDS984190I G CYSTO CDS CDS984190J G D & C CDS CDS984203F G D & C CDS CDS984203G G D & C CDS CDS984203I G D & C CDS CDS984203J G LASER VEIN CDS CDS984193M G LASER VEIN CDS CDS984193N G PELVISCOPY CDS CDS984187M G PELVISCOPY CDS CDS984187N G PELVISCOPY CDS CDS984187O G PELVISCOPY CDS CDS984187P G VAGINAL CDS CDS984201M G VAGINAL CDS CDS984201O G VAGINAL CDS CDS984201P G VAGINAL CDS CDS984201Q GU SEED PACK-RF-LF DYNJ01631F GU-GEN ROBOTIC PACK CMPJ11121 GYN LAPAROSCOPY DYNJ903869 GYN LAPAROSCOPY DYNJ901636B GYN LAPAROSCOPY DYNJ902101A GYN LAPAROSCOPY DYNJ37256D GYN LAPAROSCOPY DYNJ903869A GYN LAPAROSCOPY DYNJ903869B GYN LAPAROSCOPY DYNJ903869C GYN LAPAROSCOPY DYNJ903869D GYN LAPAROSCOPY CDS CDS983410C GYN LAPAROSCOPY CDS CDS985217D GYN LAPAROSCOPY CDS CDS983410D GYN LAPAROSCOPY CDS CDS985217F GYN LAPAROSCOPY CDS CDS983410F GYN LAPAROSCOPY CDS CDS985217G GYN LAPAROSCOPY PACK DYNJ48614C GYN LAPAROSCOPY PACK DYNJ22568F GYN LAPAROSCOPY PACK DYNJ22568G GYN LAPAROSCOPY PACK DYNJ37337G GYN LAPAROSCOPY PACK-LF DYNJ22568I GYN LAPAROSCOPY/LAVH CDS CDS981294C GYN LITHOTOMY PACK DYNJ48615B GYN ONCOLOGY ME DYNJ900201G GYN ROBOTIC DYNJ903282D GYN ROBOTIC DYNJ903282F GYN ROBOTIC DYNJ903282G GYN ROBOTIC DYNJ903282I GYN ROBOTIC DYNJ903282J GYN ROBOTIC DYNJ903282L GYN-URO LAPAROSCOPY DYNJ904856 GYN-URO LAPAROSCOPY DYNJ904856A HEAD AND NECK PACK DYNJ46509C HEART PACK A&B CMPJ22236V HH PAIN CLINIC PACK DYNJ59488 HMT CY. Recalled by Medline Industries Inc. Units affected: 92,902 kits.
Why was this product recalled? ▼
Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2040-2020.
Where was the recalled product distributed? ▼
Distribution: nationwide.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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.

Sanvall Enterprises Recalls Rapid Alivio … 2020-05-27 Primark Recalls Kitten Heel Court Shoes D… 2020-05-27 RICKER HILL ORCHARDS APPLE CIDER McIntosh… 2020-05-27 Lay's Smooth Ranch dip 15 oz. UPC 2840007… 2020-05-27

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Medtronic Nexframe Stereotactic System an… 2020-05-27 K2M, ALEUTIAN Interbody Spacer Systems, E… 2020-05-27 K2M, ALEUTIAN Interbody Spacer Systems, E… 2020-05-27 K2M, ALEUTIAN Interbody Spacer Systems, E… 2020-05-27

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported May 27, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026