Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling two models of Convenience Kits because calibration problems with sterilization and packaging equipment may have compromised the sterility of the products.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving sterilization integrity issues that pose a potential risk of harm (loss of sterile barrier protection). The source text explicitly states the calibration problems "have the potential to impact" sterility assurance, indicating a theoretical risk without reported illnesses or injuries, which fits the High (score 3) classification per the rubric.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits: DRAPE PACK (Model Number DYNJ35363A, Lot Number 21BBP020) and SICK KIDS-GENERAL CUSTOM SPLIT (Model Number SPTPCD10005, Lot Number 24JBB041). The recall affects 240 units distributed nationwide in the United States.
The company has identified calibration issues with the equipment used to sterilize and package these devices. Although all products underwent validated sterilization and packaging cycles, the identified calibration problems have the potential to impact the sterility assurance level of the recalled products.
Consumers or healthcare facilities in possession of these items should contact Medline Industries, LP for instructions on how to proceed. The FDA has classified this recall as Class II.
The recalled product
- Product
- Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
- Manufacturer
- Medline Industries, LP
- Affected units
- 240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 1) DYNJ35363A
- UDI-DI: 10884389516461(each)
- 40884389516462(case)
- Lot Number: 21BBP020
- 2) SPTPCD10005
- UDI-DI: 10080196228652(each)
- 40080196228653(case)
- Lot Number: 24JBB041
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Homecare Bed Hand Pendants Recalled for Fire Hazard
FDA (Devices) · 2026-10-07
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
- HighMedline Instrument Channel Brush Kits Recalled for Sharp Edges
FDA (Devices) · 2026-09-30
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighDrape packs recalled over sterilization equipment calibration issues
FDA (Devices) · 2026-02-25
- HighChoice drape packs recalled over sterilization equipment calibration issues
FDA (Devices) · 2026-02-25
- HighPPE kits recalled over sterilization equipment calibration issues
FDA (Devices) · 2026-02-25
- HighMedline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
FDA (Devices) · 2026-02-25
- HighMedline Convenience Kits and CPNB Setup Trays Recalled Due to Sterilization Calibration Issues
FDA (Devices) · 2026-02-25
- SevereMedline Burn Care Kits Recalled Over Sterilization Calibration Issues
FDA (Devices) · 2026-02-25