Recall Register

Device recall: Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model…

Class II FDA enforcement event 98642. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Class II, in the words of FDA

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

Medline Industries, LP started this device recall on 7 Jan 2026. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 98642 has 42 product records. The first FDA enforcement report date is 13 May 2026. The record gives the status Ongoing.

FDA enforcement reportThe 42 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Worldwide - US Nationwide distribution.

Recalling firm

Medline Industries, LP, Northfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

42 product records in the event.

FDA event 98642: product records
Recall numberProductQuantityClassStatusReport date
Z-2089-2026Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A599 unitsClass IIOngoing13 May 2026
Z-2090-2026Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY…1774 unitsClass IIOngoing13 May 2026
Z-2091-2026Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DYNJ32328; 6) OR ANGIO PACK-LF, Model…6961 unitsClass IIOngoing13 May 2026
Z-2092-2026Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A; 6) KIT ACES INSERT…39341 unitsClass IIOngoing13 May 2026
Z-2093-2026See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model…51061 unitsClass IIOngoing13 May 2026
Z-2094-2026Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number:CVI3650; 6) LINE ATTIRE KIT, Model…5562 unitsClass IIOngoing13 May 2026
Z-2095-2026Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model…4064 unitsClass IIOngoing13 May 2026
Z-2096-2026Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK3508 unitsClass IIOngoing13 May 2026
Z-2097-2026See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number:…11575 unitsClass IIOngoing13 May 2026
Z-2098-2026See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR…114778 unitsClass IIOngoing13 May 2026
Z-2099-2026See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 5) KIT PLASTIC ABDOMINOPLASTY, Model…5497 unitsClass IIOngoing13 May 2026
Z-2100-2026Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D826 unitsClass IIOngoing13 May 2026
Z-2101-2026See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CART, Model Number: ACC010542; 6) DRAWER…207196 unitsClass IIOngoing13 May 2026
Z-2102-2026Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 6) TOTE SAFRAN OSC HIP…1516 unitsClass IIOngoing13 May 2026
Z-2103-2026Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL431056 unitsClass IIOngoing13 May 2026
Z-2104-2026Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P13025 unitsClass IIOngoing13 May 2026
Z-2105-2026Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A1090 unitsClass IIOngoing13 May 2026
Z-2106-2026Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C892 unitsClass IIOngoing13 May 2026
Z-2107-2026Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT…10184 unitsClass IIOngoing13 May 2026
Z-2108-2026Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38B; 6) L & D…29192Class IIOngoing13 May 2026
Z-2109-2026See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 6)…15806 unitsClass IIOngoing13 May 2026
Z-2110-2026Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model…12529 unitsClass IIOngoing13 May 2026
Z-2111-2026Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6)…6676 unitsClass IIOngoing13 May 2026
Z-2112-2026Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431L; 6) TOT/ GYN…13376 unitsClass IIOngoing13 May 2026
Z-2113-2026Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number:…7760 unitsClass IIOngoing13 May 2026
Z-2114-2026See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number:…160980 unitsClass IIOngoing13 May 2026
Z-2115-2026Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691753 unitsClass IIOngoing13 May 2026
Z-2116-2026Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C448 unitsClass IIOngoing13 May 2026
Z-2117-2026Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE172123238 unitsClass IIOngoing13 May 2026
Z-2118-2026Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE…553 unitsClass IIOngoing13 May 2026
Z-2119-2026Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L32 unitsClass IIOngoing13 May 2026
Z-2120-2026Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437291 unitsClass IIOngoing13 May 2026
Z-2121-2026Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A108 unitsClass IIOngoing13 May 2026
Z-2122-2026Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A72 unitsClass IIOngoing13 May 2026
Z-2123-2026Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A15 unitsClass IIOngoing13 May 2026
Z-2124-2026Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005240 unitsClass IIOngoing13 May 2026
Z-2125-2026Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A9720 unitsClass IIOngoing13 May 2026
Z-2126-2026Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A59 unitsClass IIOngoing13 May 2026
Z-2127-2026Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069175 unitsClass IIOngoing13 May 2026
Z-2128-2026Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number:…14927765 unitsClass IIOngoing13 May 2026
Z-2129-2026See complete list in RES, exceeds character limit. Medline Surgical Gowns70376042 unitsClass IIOngoing13 May 2026
Z-2130-2026Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401193157 unitsClass IIOngoing13 May 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026
572
Share of these events in Class II
87%
Product records in this event
42Median of the firm: 5
Events of the firm on the register
66

Other events of the firm

Other FDA enforcement events of Medline Industries, LP
InitiatedProduct (first record)TypeClassRecords
11 Aug 2026Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199ADeviceClass I7
31 Jul 2026Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925ADeviceClass II4
23 Jul 2026Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008NDeviceClass II1
20 Jul 2026Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476ADeviceClass II13
13 Jul 2026Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product NumbeDeviceClass II3
10 Jul 2026Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330DeviceClass II1
10 Jul 2026Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295DDeviceClass II11
8 Jul 2026Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SDeviceClass II4
30 Jun 2026Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400ANDeviceClass II4
12 Jun 2026Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, MoDeviceClass II16

Medline Industries, LP: all 66 events

Official channels

Cite this page

Recall Register. FDA enforcement event 98642. https://recallregister.com/fda/ii/98642/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Worldwide - US Nationwide distribution.
What quantity of product is in FDA event 98642?
The event has 42 product records. The first record gives this quantity: 599 units
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?
87% of the 572 device events that started in 2026 are in Class II.