Medline IV Administration Kits Recalled for Defective Check Valves

Agency Publication Date: January 12, 2026

Summary

Medline Industries, LP is recalling 22,427 kits that contain B. Braun IV Administration Sets and Pump Administration Sets. These medical kits, distributed to hospitals and healthcare facilities across the United States, include various procedure packs such as open heart surgery sets, carotid anesthesia kits, and pre-op preparation kits. The recall was issued following customer complaints that the check valve components within the administration sets may become stuck in either the open or closed positions.

Risk

A check valve that is stuck in the open or closed position can disrupt the intended flow of medications or fluids to a patient. This can lead to under-infusion or over-infusion during critical medical procedures, potentially causing ineffective treatment or severe injury.

What You Should Do

This recall affects various Medline surgical and medical procedure kits that contain B. Braun IV Administration and Pump Administration Sets, including procedure packs for heart surgery, anesthesia, and IV starts.
Stop using the recalled medical kits immediately and remove them from clinical use.
Check the Medline SKU, UDI, and lot numbers printed on the kit packaging to determine if your product is affected. See the Affected Products section below for the full list of affected codes.
Contact Medline Industries, LP or your medical supply distributor to arrange for the return, replacement, or correction of the affected kits.
Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: AN01 CAROTID ANESTH KIT-LF

Model / REF:

PHS972096014B

Lot Numbers:

25JMC398

25GBY100

25IBT843

UDI:

10889942695911

Recall #: Z-1049-2026, Z-1050-2026, Z-1051-2026

Product: OPEN HEART ACCESSORY CDS

Model / REF:

CDS984289O

Lot Numbers:

25HBI736

25IMA327

UDI:

10198459418143

Recall #: Z-1050-2026, Z-1051-2026

Product: BASIC CARDIAC ANESTHESIA

Model / REF:

DYNJ903523F

Lot Numbers:

25HBL296

25HBN030

25JLA937

25IMI028

UDI:

10198459316593

Recall #: Z-1050-2026, Z-1051-2026

Product: OPEN HEART CDS

Model / REF:

DYNJ902879T

Lot Numbers:

25HLA445

25IBL774

25IMG620

25JBO555

25KBH512

UDI:

10195327461294

Recall #: Z-1050-2026

Product: BAG A OPEN HEART KIT

Model / REF:

DYKM1025D

Lot Numbers:

25HMA140

UDI:

10195327482893

Recall #: Z-1050-2026

Product: RR-CABG SUPPLEMENTAL PACK

Model / REF:

DYNJ0394752O

Lot Numbers:

25IBI197

25IMH657

UDI:

10193489432794

Recall #: Z-1050-2026

Product: AN03 HEART/ANESTHESIA KIT-LF

Model / REF:

PHS972012D

Lot Numbers:

25IMH924

UDI:

10193489571875

Recall #: Z-1050-2026

Product: OPEN HEART CDS

Model / REF:

DYNJ905557B

Lot Numbers:

25JBH529

UDI:

10193489468243

Recall #: Z-1050-2026

Product: OPEN HEART CDS

Model / REF:

CDS984355K

Lot Numbers:

25KBB119

UDI:

10198459258848

Recall #: Z-1050-2026

Product: RR-LE FORT MANDIBLE PACK-LF

Model / REF:

DYNJ0785864R

Lot Numbers:

25HMB184

UDI:

10195327656454

Recall #: Z-1052-2026

Product: RR-ASC EAR PACK-LF

Model / REF:

DYNJ0792607R

Lot Numbers:

25JMH400

UDI:

10198459503023

Recall #: Z-1052-2026

Product: RR-LAP DONOR NEP ACCESSORY

Model / REF:

DYNJ63395B

Lot Numbers:

25HLA435

25HLB046

UDI:

10195327634698

Recall #: Z-1053-2026

Product: DR HOLCOMB FACIAL PACK

Model / REF:

DYNJ54488A

Lot Numbers:

25HBQ850

UDI:

10193489587869

Recall #: Z-1054-2026

Product: DRAWER 2 IV SUPPLIES

Model / REF:

ACC010271B

Lot Numbers:

25IDB125

25IDB400

25JDB835

25KDA036

25KDA248

UDI:

10193489484953

Recall #: Z-1055-2026

Product: DRAWER 2 IV FLUIDS & TUBING

Model / REF:

ACC010416B

Lot Numbers:

25IDA545

25JDB867

UDI:

10195327223670

Recall #: Z-1055-2026

Product: OXYGENATION & TUBING TRAY

Model / REF:

ACC010525C

Lot Numbers:

25KDA768

UDI:

10198459027765

Recall #: Z-1055-2026

Product: TOP DRAWER #6

Model / REF:

ACC010688

Lot Numbers:

25HDB656

25IDA638

25JDA666

UDI:

10195327432713

Recall #: Z-1055-2026

Product: RRMC CODE CART DRAWER 3

Model / REF:

ACC010770

Lot Numbers:

25HDA878

25IDA087

25IDA817

25JDB317

UDI:

10195327576998

Recall #: Z-1055-2026

Product: SURGERY BAG

Model / REF:

DYKM1279C

Lot Numbers:

25IBL412

25KBK165

UDI:

10889942519583

Recall #: Z-1055-2026

Product: ADMISSION KIT

Model / REF:

DYKS1179

Lot Numbers:

25IMD671

25JMG868

UDI:

10193489711981

Recall #: Z-1055-2026

Product: PRE OP KIT

Model / REF:

DYKS1192C

Lot Numbers:

25KME757

UDI:

10193489849707

Recall #: Z-1055-2026

Product: MEDLINE PEDIATRIC PATIENT PACK

Model / REF:

DYKS1199B

Lot Numbers:

25HBF059

25JBU391

UDI:

10193489403831

Recall #: Z-1055-2026

Product: MEDLINE ADULT PATIENT PACKAGE

Model / REF:

DYKS1200B

Lot Numbers:

25IBT744

25KBG976

UDI:

10193489235425

Recall #: Z-1055-2026

Product: GERMANTOWN PRE OP KIT

Model / REF:

DYKS1248

Lot Numbers:

25JBS281

UDI:

10193489305708

Recall #: Z-1055-2026

Product: GERMANTOWN PRE OP BLOCK KIT

Model / REF:

DYKS1249

Lot Numbers:

25HBJ008

25HBV936

25IBB540

UDI:

10193489305715

Recall #: Z-1055-2026

Product: PRE OP KIT

Model / REF:

DYKS1274A

Lot Numbers:

25HBF086

25IBF923

UDI:

10195327058890

Recall #: Z-1055-2026

Product: CATH LAB PRE OP START KIT

Model / REF:

DYKS1324

Lot Numbers:

25IBR790

UDI:

10193489969962

Recall #: Z-1055-2026

Product: PRE OP KIT

Model / REF:

DYKS1376

Lot Numbers:

25HBF087

25IBS865

UDI:

10195327216498

Recall #: Z-1055-2026

Product: PTC KIT

Model / REF:

DYNDH1161A

Lot Numbers:

25HBG750

UDI:

10889942731299

Recall #: Z-1055-2026

Product: DR BROWN BODY

Model / REF:

DYNJ910487

Lot Numbers:

25GMK728

25HMI417

UDI:

10198459004841

Recall #: Z-1055-2026

Product: IV START KIT NS

Model / REF:

DYKM1980C

Lot Numbers:

25JBB147

25KBL305

UDI:

10195327608309

Recall #: Z-1056-2026

Product: (134) L&D IV-START SET

Model / REF:

DYKM2137B

Lot Numbers:

25HBT834

25IBJ757

25JBJ557

UDI:

10198459285615

Recall #: Z-1056-2026

Product: IV START KIT

Model / REF:

DYKS1372C

Lot Numbers:

25JLA480

UDI:

10195327373504

Recall #: Z-1056-2026

Product: IV START KIT

Model / REF:

DYNDV1691B

Lot Numbers:

25HBI335

25IBE523

25JBM702

UDI:

10195327658472

Recall #: Z-1056-2026

Product: OUTPATIENT 2 TO 5 YEARS

Model / REF:

DYNDV2464A

Lot Numbers:

25IBV942

UDI:

10195327065911

Recall #: Z-1056-2026

Product: PRE-OP - OUTPATIENT KIT

Model / REF:

DYKS1378B

Lot Numbers:

25HBB410

25IBI706

UDI:

10195327521660

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS1448B

Lot Numbers:

25HBE055

25JBO961

UDI:

10195327691349

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1163G

Lot Numbers:

25HBF057

25IBQ969

UDI:

10195327503185

Recall #: Z-1057-2026

Product: ADULT PRE OP

Model / REF:

DYKS1487I

Lot Numbers:

25HBI512

25JBJ439

UDI:

10198459415678

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS2056A

Lot Numbers:

25HBK906

UDI:

10198459467493

Recall #: Z-1057-2026

Product: PRE-OP KIT

Model / REF:

DYKS2074

Lot Numbers:

25HBV987

UDI:

10198459399893

Recall #: Z-1057-2026

Product: PRE OP KIT 1

Model / REF:

DYKS2083

Lot Numbers:

25HLA076

UDI:

10198459435126

Recall #: Z-1057-2026

Product: PREOP

Model / REF:

DYKS1552B

Lot Numbers:

25HLA432

25JLA660

25KLA029

UDI:

10198459269523

Recall #: Z-1057-2026

Product: PRE OP KIT ADULT

Model / REF:

DYKS1362A

Lot Numbers:

25HLA829

25KLA016

UDI:

10195327343163

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1124C

Lot Numbers:

25HMB303

25HMF480

25JMD403

UDI:

10198459447877

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS1313A

Lot Numbers:

25HMB948

25JMH456

UDI:

10198459370595

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1544F

Lot Numbers:

25HMC488

25JMD404

UDI:

10198459411700

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS1507B

Lot Numbers:

25HMD440

UDI:

10198459489372

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS1130B

Lot Numbers:

25IBC508

UDI:

10198459377129

Recall #: Z-1057-2026

Product: PREOP

Model / REF:

DYKS1551B

Lot Numbers:

25IBK720

25JBC342

25JBE269

UDI:

10198459347702

Recall #: Z-1057-2026

Product: PREOP

Model / REF:

DYKS1580

Lot Numbers:

25IBL590

25JBU194

UDI:

10198459024320

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS2076

Lot Numbers:

25IBL885

25JBE865

25JBJ451

UDI:

10198459399732

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1518A

Lot Numbers:

25IBU385

UDI:

10198459032448

Recall #: Z-1057-2026

Product: PRE OP ENDO

Model / REF:

DYKS1489F

Lot Numbers:

25IBW167

UDI:

10198459291272

Recall #: Z-1057-2026

Product: ADULT PRE OP KIT

Model / REF:

DYKS1337D

Lot Numbers:

25ILA943

25KLA107

UDI:

10198459078415

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1468

Lot Numbers:

25ILA944

25KLA028

UDI:

10195327411213

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1467B

Lot Numbers:

25IME692

25KME034

UDI:

10198459025648

Recall #: Z-1057-2026

Product: PRE-OP INPATIENT KIT

Model / REF:

DYKS1379B

Lot Numbers:

25JBB244

25JBU341

25KBL301

UDI:

10195327387433

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1128C

Lot Numbers:

25JBG502

25KBH159

UDI:

10195327549374

Recall #: Z-1057-2026

Product: PRE OP KIT SURGERY

Model / REF:

DYKS1263G

Lot Numbers:

25JBL575

UDI:

10198459557330

Recall #: Z-1057-2026

Product: PRE-OP

Model / REF:

DYKS1482A

Lot Numbers:

25JBR391

UDI:

10198459011368

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1382A

Lot Numbers:

25JBS091

UDI:

10195327482602

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1325A

Lot Numbers:

25JBU577

UDI:

10195327549343

Recall #: Z-1057-2026

Product: PRE-OP KIT

Model / REF:

DYKS1458F

Lot Numbers:

25JLA986

UDI:

10198459477942

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1416F

Lot Numbers:

25JLB077

UDI:

10198459508561

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1093B

Lot Numbers:

25JMF248

UDI:

10198459544545

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS2103

Lot Numbers:

25JML466

UDI:

10198459550539

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS2024A

Lot Numbers:

25KBC077

UDI:

10198459547201

Recall #: Z-1057-2026

Product: PRE-OP KIT

Model / REF:

DYKS2074A

Lot Numbers:

25KME090

UDI:

10198459528651

Recall #: Z-1057-2026

Product: ADMIN KIT

Model / REF:

DYKS1339B

Lot Numbers:

25HMC849

UDI:

10195327386726

Recall #: Z-1058-2026

Product: ADMIN KIT

Model / REF:

DYKS1339C

Lot Numbers:

25IMG807

25JMF937

UDI:

10198459523434

Recall #: Z-1058-2026

Product: QCASC WELCOME KIT

Model / REF:

DYKS1359B

Lot Numbers:

25JMD518

UDI:

10195327566449

Recall #: Z-1058-2026

Product: ADMISSION KIT

Model / REF:

DYKS1534D

Lot Numbers:

25HMD322

25JMG543

UDI:

10198459310911

Recall #: Z-1058-2026

Product: NEURO ANGIO PACK

Model / REF:

DYNJ38935

Lot Numbers:

25IBC144

UDI:

10884389725092

Recall #: Z-1059-2026

Product: RR-PLASTIC CRANIOFACIAL PK-LF

Model / REF:

DYNJ0395085V

Lot Numbers:

25HMC337

UDI:

10198459313745

Recall #: Z-1060-2026

Product: NH PERI DISC PACK

Model / REF:

DYNJ66311C

Lot Numbers:

25KBG419

UDI:

10198459364556

Recall #: Z-1060-2026

Product: DISCECTOMY PACK

Model / REF:

DYNJ86770

Lot Numbers:

25IBU284

25KBJ623

UDI:

10195327674229

Recall #: Z-1060-2026

Product: TOTAL KNEE

Model / REF:

DYNJ909643F

Lot Numbers:

25HBU964

25IBV819

25KBF028

UDI:

10198459392603

Recall #: Z-1060-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98154

Status: Active

Manufacturer: Medline Industries, LP

Sold By: Medical supply distributors; Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 12 products (10 units; 633 units; 32 units; 96 units; 33 units; 16 units; 3045 units; 5314 units; 11173 units; 1725 units; 12 units; 338 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects various Medline surgical and medical procedure kits that contain B. Braun IV Administration and Pump Administration Sets, including procedure packs for heart surgery, anesthesia, and IV starts.

Stop using the recalled medical kits immediately and remove them from clinical use.

Check the Medline SKU, UDI, and lot numbers printed on the kit packaging to determine if your product is affected. See the Affected Products section below for the full list of affected codes.

Contact Medline Industries, LP or your medical supply distributor to arrange for the return, replacement, or correction of the affected kits.

Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Affected Products

Product: AN01 CAROTID ANESTH KIT-LF

Model / REF:

PHS972096014B

Lot Numbers:

25JMC398

25GBY100

25IBT843

UDI:

10889942695911

Recall #: Z-1049-2026, Z-1050-2026, Z-1051-2026

Product: OPEN HEART ACCESSORY CDS

Model / REF:

CDS984289O

Lot Numbers:

25HBI736

25IMA327

UDI:

10198459418143

Recall #: Z-1050-2026, Z-1051-2026

Product: BASIC CARDIAC ANESTHESIA

Model / REF:

DYNJ903523F

Lot Numbers:

25HBL296

25HBN030

25JLA937

25IMI028

UDI:

10198459316593

Recall #: Z-1050-2026, Z-1051-2026

Product: OPEN HEART CDS

Model / REF:

DYNJ902879T

Lot Numbers:

25HLA445

25IBL774

25IMG620

25JBO555

25KBH512

UDI:

10195327461294

Recall #: Z-1050-2026

Product: BAG A OPEN HEART KIT

Model / REF:

DYKM1025D

Lot Numbers:

25HMA140

UDI:

10195327482893

Recall #: Z-1050-2026

Product: RR-CABG SUPPLEMENTAL PACK

Model / REF:

DYNJ0394752O

Lot Numbers:

25IBI197

25IMH657

UDI:

10193489432794

Recall #: Z-1050-2026

Product: AN03 HEART/ANESTHESIA KIT-LF

Model / REF:

PHS972012D

Lot Numbers:

25IMH924

UDI:

10193489571875

Recall #: Z-1050-2026

Product: OPEN HEART CDS

Model / REF:

DYNJ905557B

Lot Numbers:

25JBH529

UDI:

10193489468243

Recall #: Z-1050-2026

Product: OPEN HEART CDS

Model / REF:

CDS984355K

Lot Numbers:

25KBB119

UDI:

10198459258848

Recall #: Z-1050-2026

Product: RR-LE FORT MANDIBLE PACK-LF

Model / REF:

DYNJ0785864R

Lot Numbers:

25HMB184

UDI:

10195327656454

Recall #: Z-1052-2026

Product: RR-ASC EAR PACK-LF

Model / REF:

DYNJ0792607R

Lot Numbers:

25JMH400

UDI:

10198459503023

Recall #: Z-1052-2026

Product: RR-LAP DONOR NEP ACCESSORY

Model / REF:

DYNJ63395B

Lot Numbers:

25HLA435

25HLB046

UDI:

10195327634698

Recall #: Z-1053-2026

Product: DR HOLCOMB FACIAL PACK

Model / REF:

DYNJ54488A

Lot Numbers:

25HBQ850

UDI:

10193489587869

Recall #: Z-1054-2026

Product: DRAWER 2 IV SUPPLIES

Model / REF:

ACC010271B

Lot Numbers:

25IDB125

25IDB400

25JDB835

25KDA036

25KDA248

UDI:

10193489484953

Recall #: Z-1055-2026

Product: DRAWER 2 IV FLUIDS & TUBING

Model / REF:

ACC010416B

Lot Numbers:

25IDA545

25JDB867

UDI:

10195327223670

Recall #: Z-1055-2026

Product: OXYGENATION & TUBING TRAY

Model / REF:

ACC010525C

Lot Numbers:

25KDA768

UDI:

10198459027765

Recall #: Z-1055-2026

Product: TOP DRAWER #6

Model / REF:

ACC010688

Lot Numbers:

25HDB656

25IDA638

25JDA666

UDI:

10195327432713

Recall #: Z-1055-2026

Product: RRMC CODE CART DRAWER 3

Model / REF:

ACC010770

Lot Numbers:

25HDA878

25IDA087

25IDA817

25JDB317

UDI:

10195327576998

Recall #: Z-1055-2026

Product: SURGERY BAG

Model / REF:

DYKM1279C

Lot Numbers:

25IBL412

25KBK165

UDI:

10889942519583

Recall #: Z-1055-2026

Product: ADMISSION KIT

Model / REF:

DYKS1179

Lot Numbers:

25IMD671

25JMG868

UDI:

10193489711981

Recall #: Z-1055-2026

Product: PRE OP KIT

Model / REF:

DYKS1192C

Lot Numbers:

25KME757

UDI:

10193489849707

Recall #: Z-1055-2026

Product: MEDLINE PEDIATRIC PATIENT PACK

Model / REF:

DYKS1199B

Lot Numbers:

25HBF059

25JBU391

UDI:

10193489403831

Recall #: Z-1055-2026

Product: MEDLINE ADULT PATIENT PACKAGE

Model / REF:

DYKS1200B

Lot Numbers:

25IBT744

25KBG976

UDI:

10193489235425

Recall #: Z-1055-2026

Product: GERMANTOWN PRE OP KIT

Model / REF:

DYKS1248

Lot Numbers:

25JBS281

UDI:

10193489305708

Recall #: Z-1055-2026

Product: GERMANTOWN PRE OP BLOCK KIT

Model / REF:

DYKS1249

Lot Numbers:

25HBJ008

25HBV936

25IBB540

UDI:

10193489305715

Recall #: Z-1055-2026

Product: PRE OP KIT

Model / REF:

DYKS1274A

Lot Numbers:

25HBF086

25IBF923

UDI:

10195327058890

Recall #: Z-1055-2026

Product: CATH LAB PRE OP START KIT

Model / REF:

DYKS1324

Lot Numbers:

25IBR790

UDI:

10193489969962

Recall #: Z-1055-2026

Product: PRE OP KIT

Model / REF:

DYKS1376

Lot Numbers:

25HBF087

25IBS865

UDI:

10195327216498

Recall #: Z-1055-2026

Product: PTC KIT

Model / REF:

DYNDH1161A

Lot Numbers:

25HBG750

UDI:

10889942731299

Recall #: Z-1055-2026

Product: DR BROWN BODY

Model / REF:

DYNJ910487

Lot Numbers:

25GMK728

25HMI417

UDI:

10198459004841

Recall #: Z-1055-2026

Product: IV START KIT NS

Model / REF:

DYKM1980C

Lot Numbers:

25JBB147

25KBL305

UDI:

10195327608309

Recall #: Z-1056-2026

Product: (134) L&D IV-START SET

Model / REF:

DYKM2137B

Lot Numbers:

25HBT834

25IBJ757

25JBJ557

UDI:

10198459285615

Recall #: Z-1056-2026

Product: IV START KIT

Model / REF:

DYKS1372C

Lot Numbers:

25JLA480

UDI:

10195327373504

Recall #: Z-1056-2026

Product: IV START KIT

Model / REF:

DYNDV1691B

Lot Numbers:

25HBI335

25IBE523

25JBM702

UDI:

10195327658472

Recall #: Z-1056-2026

Product: OUTPATIENT 2 TO 5 YEARS

Model / REF:

DYNDV2464A

Lot Numbers:

25IBV942

UDI:

10195327065911

Recall #: Z-1056-2026

Product: PRE-OP - OUTPATIENT KIT

Model / REF:

DYKS1378B

Lot Numbers:

25HBB410

25IBI706

UDI:

10195327521660

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS1448B

Lot Numbers:

25HBE055

25JBO961

UDI:

10195327691349

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1163G

Lot Numbers:

25HBF057

25IBQ969

UDI:

10195327503185

Recall #: Z-1057-2026

Product: ADULT PRE OP

Model / REF:

DYKS1487I

Lot Numbers:

25HBI512

25JBJ439

UDI:

10198459415678

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS2056A

Lot Numbers:

25HBK906

UDI:

10198459467493

Recall #: Z-1057-2026

Product: PRE-OP KIT

Model / REF:

DYKS2074

Lot Numbers:

25HBV987

UDI:

10198459399893

Recall #: Z-1057-2026

Product: PRE OP KIT 1

Model / REF:

DYKS2083

Lot Numbers:

25HLA076

UDI:

10198459435126

Recall #: Z-1057-2026

Product: PREOP

Model / REF:

DYKS1552B

Lot Numbers:

25HLA432

25JLA660

25KLA029

UDI:

10198459269523

Recall #: Z-1057-2026

Product: PRE OP KIT ADULT

Model / REF:

DYKS1362A

Lot Numbers:

25HLA829

25KLA016

UDI:

10195327343163

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1124C

Lot Numbers:

25HMB303

25HMF480

25JMD403

UDI:

10198459447877

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS1313A

Lot Numbers:

25HMB948

25JMH456

UDI:

10198459370595

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1544F

Lot Numbers:

25HMC488

25JMD404

UDI:

10198459411700

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS1507B

Lot Numbers:

25HMD440

UDI:

10198459489372

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS1130B

Lot Numbers:

25IBC508

UDI:

10198459377129

Recall #: Z-1057-2026

Product: PREOP

Model / REF:

DYKS1551B

Lot Numbers:

25IBK720

25JBC342

25JBE269

UDI:

10198459347702

Recall #: Z-1057-2026

Product: PREOP

Model / REF:

DYKS1580

Lot Numbers:

25IBL590

25JBU194

UDI:

10198459024320

Recall #: Z-1057-2026

Product: PREOP KIT

Model / REF:

DYKS2076

Lot Numbers:

25IBL885

25JBE865

25JBJ451

UDI:

10198459399732

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1518A

Lot Numbers:

25IBU385

UDI:

10198459032448

Recall #: Z-1057-2026

Product: PRE OP ENDO

Model / REF:

DYKS1489F

Lot Numbers:

25IBW167

UDI:

10198459291272

Recall #: Z-1057-2026

Product: ADULT PRE OP KIT

Model / REF:

DYKS1337D

Lot Numbers:

25ILA943

25KLA107

UDI:

10198459078415

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1468

Lot Numbers:

25ILA944

25KLA028

UDI:

10195327411213

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1467B

Lot Numbers:

25IME692

25KME034

UDI:

10198459025648

Recall #: Z-1057-2026

Product: PRE-OP INPATIENT KIT

Model / REF:

DYKS1379B

Lot Numbers:

25JBB244

25JBU341

25KBL301

UDI:

10195327387433

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1128C

Lot Numbers:

25JBG502

25KBH159

UDI:

10195327549374

Recall #: Z-1057-2026

Product: PRE OP KIT SURGERY

Model / REF:

DYKS1263G

Lot Numbers:

25JBL575

UDI:

10198459557330

Recall #: Z-1057-2026

Product: PRE-OP

Model / REF:

DYKS1482A

Lot Numbers:

25JBR391

UDI:

10198459011368

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1382A

Lot Numbers:

25JBS091

UDI:

10195327482602

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1325A

Lot Numbers:

25JBU577

UDI:

10195327549343

Recall #: Z-1057-2026

Product: PRE-OP KIT

Model / REF:

DYKS1458F

Lot Numbers:

25JLA986

UDI:

10198459477942

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1416F

Lot Numbers:

25JLB077

UDI:

10198459508561

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS1093B

Lot Numbers:

25JMF248

UDI:

10198459544545

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS2103

Lot Numbers:

25JML466

UDI:

10198459550539

Recall #: Z-1057-2026

Product: PRE OP KIT

Model / REF:

DYKS2024A

Lot Numbers:

25KBC077

UDI:

10198459547201

Recall #: Z-1057-2026

Product: PRE-OP KIT

Model / REF:

DYKS2074A

Lot Numbers:

25KME090

UDI:

10198459528651

Recall #: Z-1057-2026

Product: ADMIN KIT

Model / REF:

DYKS1339B

Lot Numbers:

25HMC849

UDI:

10195327386726

Recall #: Z-1058-2026

Product: ADMIN KIT

Model / REF:

DYKS1339C

Lot Numbers:

25IMG807

25JMF937

UDI:

10198459523434

Recall #: Z-1058-2026

Product: QCASC WELCOME KIT

Model / REF:

DYKS1359B

Lot Numbers:

25JMD518

UDI:

10195327566449

Recall #: Z-1058-2026

Product: ADMISSION KIT

Model / REF:

DYKS1534D

Lot Numbers:

25HMD322

25JMG543

UDI:

10198459310911

Recall #: Z-1058-2026

Product: NEURO ANGIO PACK

Model / REF:

DYNJ38935

Lot Numbers:

25IBC144

UDI:

10884389725092

Recall #: Z-1059-2026

Product: RR-PLASTIC CRANIOFACIAL PK-LF

Model / REF:

DYNJ0395085V

Lot Numbers:

25HMC337

UDI:

10198459313745

Recall #: Z-1060-2026

Product: NH PERI DISC PACK

Model / REF:

DYNJ66311C

Lot Numbers:

25KBG419

UDI:

10198459364556

Recall #: Z-1060-2026

Product: DISCECTOMY PACK

Model / REF:

DYNJ86770

Lot Numbers:

25IBU284

25KBJ623

UDI:

10195327674229

Recall #: Z-1060-2026

Product: TOTAL KNEE

Model / REF:

DYNJ909643F

Lot Numbers:

25HBU964

25IBV819

25KBF028

UDI:

10198459392603

Recall #: Z-1060-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98154

Status: Active

Manufacturer: Medline Industries, LP

Sold By: Medical supply distributors; Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 12 products (10 units; 633 units; 32 units; 96 units; 33 units; 16 units; 3045 units; 5314 units; 11173 units; 1725 units; 12 units; 338 units)

Distributed To: Nationwide