RecallHawk
Class II Recall

Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRAN

Medline Industries, LP

Summary

The FDA issued a Class II for Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product by Medline Industries, LP. Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribut.

Details

Source

Device Recall

External ID

Z-0179-2027

Action Date

2026-10-21

Status

Ongoing

Category

device

Product Description

Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU DYNJ67139D; 5) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AD; 6) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333K; 7) EXTREMITY-LF, Medline Product Number/SKU DYNJ905276F; 8) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AC; 9) SPINAL CDS, Medline Product Number/SKU CDS940087AL; 10) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697A; 11) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055; 12) CRANIOTOMY-RICHMOND, Medline Product Number/SKU CDS980929U; 13) ACB EXTRAS PACK-6211, Medline Product Number/SKU DYNJ49516; 14) SPINAL CDS, Medline Product Number/SKU CDS940087AK; 15) SPINAL CDS, Medline Product Number/SKU CDS940087AJ; 16) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AB; 17) SPINAL CDS, Medline Product Number/SKU CDS940087AI; 18) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333J; 19) SPINAL CDS, Medline Product Number/SKU CDS940087AG; 20) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AA.

Lot/Code Info: Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMG028; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMF181; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26DMD186; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26CMA323; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 26BMJ234; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 26ALA854; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADB485; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 26ADA395; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 26ABM111; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25LBH825; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMC475; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25KMB629; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25KLA526; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25KBP981; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25JDB519; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25JBI857; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25IMC513; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ILA706; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25IDB222; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25IBP736; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25HLA065; Medline Product Number/SKU CDS780025AD, UDI/DI 10198459311598 (each) 40198459311599 (case), Lot Number 25HBO604; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25GDB198; Medline Product Number/SKU DYNJ905276F, UDI/DI 10198459247965 (each) 40198459247966 (case), Lot Number 25GBS381; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25GBQ923; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25GBJ981; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25FLA160; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25FDA332; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25FBN175; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25EBV301; Medline Product Number/SKU CDS940087AM, UDI/DI 10198459311499 (each) 40198459311490 (case), Lot Number 25EBH152; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25DLA962; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 25DDB837; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 25DDA286; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25DBC339; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25CLA883; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 25CBS904; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 25CBP237; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25CBG304; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 25CBE419; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA976; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA345; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 25ALA067; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 25ABU061; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24LBE127; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24KLA163; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24KBR641; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24KBD715; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24JLA181; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24JDA289; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24JBQ903; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24JBQ698; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24JBG248; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24IBK612; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24HBT188; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24GDA765; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24GBE280; Medline Product Number/SKU DYNJ907697C, UDI/DI 10195327697617 (each) 40195327697618 (case), Lot Number 24FLA764; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 24FDA385; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24FBN519; Medline Product Number/SKU DYNJ67139D, UDI/DI 10195327668273 (each) 40195327668274 (case), Lot Number 24FBM920; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24FBE685; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24DDB513; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24DDA174; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24DBH403; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24CBP710; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 24BLA540; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24BBS351; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24BBR356; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 24BBI372; Medline Product Number/SKU DYNJ80055, UDI/DI 10195327008741 (each) 40195327008742 (case), Lot Number 24BBD195; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 24BBB443; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 24ADC061; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 24ADA704; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 23LLA416; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23LDA917; Medline Product Number/SKU CDS980929U, UDI/DI 10193489976427 (each) 40193489976428 (case), Lot Number 23LBC788; Medline Product Number/SKU DYNJ907697A, UDI/DI 10195327536459 (each) 40195327536450 (case), Lot Number 23KLB157; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23KDA615; Medline Product Number/SKU CDS980929U, UDI/DI 10193489976427 (each) 40193489976428 (case), Lot Number 23KBT094; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23KBP002; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23KBN905; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23KBC083; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23JDB177; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23IDB906; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23IDB810; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23IBW076; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23IBI612; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23IBD027; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23HBP378; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23GDC095; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23FDB307; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23FBI843; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23FBH173; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23EBL944; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23EBJ659; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23DDB819; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23DBN024; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23CDA324; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 23CBX130; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 23BDB285; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 23ADB644; Medline Product Number/SKU CDS940087AL, UDI/DI 10195327297824 (each) 40195327297825 (case), Lot Number 23ABB068; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22LBM685; Medline Product Number/SKU CDS940087AK, UDI/DI 10195327257514 (each) 40195327257515 (case), Lot Number 22LBG216; Medline Product Number/SKU CDS780025AC, UDI/DI 10195327212278 (each) 40195327212279 (case), Lot Number 22LBF788; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22LBC322; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22KDB263; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 22KDA291; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22JDA178; Medline Product Number/SKU DYNJ0159820F, UDI/DI 10193489207057 (each) 40193489207058 (case), Lot Number 22IDA027; Medline Product Number/SKU CDS940087AJ, UDI/DI 10195327210427 (each) 40195327210428 (case), Lot Number 22HBO525; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22HBB637; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22GDA892; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22GBH493; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22GBE442; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22EBN090; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBG548; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBF695; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22EBA274; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 22CBP174; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 22BDC466; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 22BBY060; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 22BBP492; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21LBU758; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21KBH163; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21JBF936; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21IBL720; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21IBJ260; Medline Product Number/SKU CDS780025AB, UDI/DI 10193489846966 (each) 40193489846967 (case), Lot Number 21HBL624; Medline Product Number/SKU DYNJ17333K, UDI/DI 10193489948998 (each) 40193489948999 (case), Lot Number 21GDD271; Medline Product Number/SKU CDS940087AI, UDI/DI 10193489933758 (each) 40193489933759 (case), Lot Number 21GBI183; Medline Product Number/SKU DYNJ49516, UDI/DI 10888277854369 (each) 40888277854360 (case), Lot Number 21FBB329; Medline Product Number/SKU DYNJ17333J, UDI/DI 10193489791525 (each) 40193489791526 (case), Lot Number 21EDB082; Medline Product Number/SKU CDS940087AG, UDI/DI 10193489847260 (each) 40193489847261 (case), Lot Number 21EBC900; Medline Product Number/SKU DYNJ17333J, UDI/DI 10193489791525 (each) 40193489791526 (case), Lot Number 21CDA517; Medline Product Number/SKU CDS780025AA, UDI/DI 10193489483932 (each) 40193489483933 (case), Lot Number 21CBD927.

Quantity Affected: 6069 kits

Reason for Recall

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-09-02

Company

Medline Industries, LP

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.

Medline Industries, LP has 607 FDA actions in our database, including 576 recalls and 31 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 607 FDA actions in our database, including 576 recalls and 31 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0179-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29