Surgical and Medical Procedure Packs Recalled for Sterilization Issues

Agency Publication Date: March 14, 2025

Summary

American Contract Systems Inc (ACS) is recalling approximately 12,369 surgical and medical procedure packs because the company cannot confirm that sterilization requirements were met. The recall involves dozens of different specialized kits, including laparoscopy, C-section, injection, and labor and delivery packs used in surgical settings. While no injuries or infections have been reported to date, the loss of sterilization assurance could lead to defective products or delays in medical treatment.

Risk

A failure in the sterilization process means the surgical tools and medical supplies inside these packs may not be sterile, potentially introducing contaminants during a procedure. This issue may cause medical devices to malfunction or lead to significant treatment delays if a pack is found to be compromised during surgery.

What You Should Do

This recall affects dozens of surgical and medical procedure packs produced by American Contract Systems Inc, including Laparoscopy Packs, C-Section Packs, Labor & Delivery Packs, and various surgical trays.
Identify if you have the affected products by checking the model numbers, lot numbers, and Unique Device Identifiers (UDI) printed on the product labeling. See the Affected Products section below for the full list of affected codes.
Stop using the recalled surgical and medical packs immediately and quarantine any remaining stock to prevent further use in clinical procedures.
Contact American Contract Systems Inc or your authorized distributor to arrange for the return, replacement, or correction of the affected kits.
Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled surgical pack or medical device kit immediately. Contact American Contract Systems Inc or your distributor to arrange for a return, replacement, or correction of the affected equipment.

Affected Products

Product: LAPAROSCOPY PACK

Model / REF:

CALS41F

CALS41F-01

CALS41G

Lot Numbers:

962241

70-050280

70-050870

70-051556

70-052412

70-053051

UDI:

00191072215727

00191072233332

Recall #: Z-1331-2025

Product: DR DIULUS INJECTION PACK

Model / REF:

CCDU12C

CCDU12D

CCDU12D-01

Lot Numbers:

968241

70-050508

70-050945

70-051497

70-051882

70-052444

70-052967

UDI:

00191072196323

00191072229472

Recall #: Z-1332-2025

Product: HIP SCOPE

Model / REF:

CCHS21B

CCHS21B-01

CCHS21B-02

Lot Numbers:

962241

914241

70-050890

70-051579

70-052206

70-053085

UDI:

00191072193483

Recall #: Z-1333-2025

Product: MAJOR DIEP

Model / REF:

CCMJ73G-01

CCMJ73H

Lot Numbers:

879241

70-052915

UDI:

00191072222824

00191072223890

Recall #: Z-1334-2025

Product: CYSTO PACK

Model / REF:

HKCY31A

Lot Numbers:

933241

70-051382

70-052664

UDI:

00191072059093

Recall #: Z-1335-2025

Product: C-SECTION PACK

Model / REF:

LLCS44F

LLCS44F-01

Lot Numbers:

70-051011

70-051709

70-052452

70-052952

UDI:

00191072219107

Recall #: Z-1336-2025

Product: LAPAROSCOPY PACK

Model / REF:

LLLA21J

LLLA21J-02

Lot Numbers:

882241

70-051163

70-051373

70-051564

70-052582

70-053048

UDI:

00191072219206

Recall #: Z-1337-2025

Product: LABOR & DELIVERY PACK

Model / REF:

LLLD19H

Lot Numbers:

885241

70-051324

70-051967

70-052455

70-053006

UDI:

00191072219213

Recall #: Z-1338-2025

Product: OPEN HEART ADULT - SIDE A

Model / REF:

LLOH01I-01

LLOH01I

Lot Numbers:

898241

70-050704

70-051731

UDI:

00191072219251

Recall #: Z-1339-2025

Product: GENERAL ANGIO PACK

Model / REF:

LLAP75G

LLAP75G-01

LLAP75G-02

LLAP75G-03

Lot Numbers:

70-050850

70-051285

70-051779

70-051779A

70-052186

70-052669

70-053022

UDI:

00191072219510

Recall #: Z-1340-2025

Product: BORN ON ARRIVAL KIT

Model / REF:

LLBN11B

Lot Numbers:

891241

70-051710

70-052354

UDI:

00191072219558

Recall #: Z-1341-2025

Product: C-SECTION PPS

Model / REF:

LLCI66M

LLCI66M-02

LLCI66M-03

LLCI66M-04

Lot Numbers:

907241

70-050816

70-051301

70-051839

70-052420

70-052910

70-053100

UDI:

00191072219596

Recall #: Z-1342-2025

Product: CENTRAL LINE PICC

Model / REF:

LLCL44H

LLCL44H-01

Lot Numbers:

70-050707

70-050860

70-051149

70-051713

70-052363

70-053044

UDI:

00191072219602

Recall #: Z-1343-2025

Product: LABOR & DELIVERY PPS

Model / REF:

LLLD64O

LLLD64O-01

LLLD64O-02

Lot Numbers:

892241

70-051048

70-051516

70-052113

70-052313

70-052401

70-052911

UDI:

00191072219794

Recall #: Z-1344-2025

Product: URO ROBOTIC PACK

Model / REF:

LVUR44C

LVUR44C-03

Lot Numbers:

905241

70-050739

70-051020

70-051480

70-051606

70-051888

UDI:

00191072136688

Recall #: Z-1345-2025

Product: CYSTO

Model / REF:

SACY80R

Lot Numbers:

70-51139

70-052248

70-052564

70-052954

UDI:

00191072223425

Recall #: Z-1346-2025

Product: TOTAL HIP PACK

Model / REF:

SMTH06O

SMTH06P

Lot Numbers:

969241

928241

70-051508

70-052517

UDI:

00191072163882

00191072229601

Recall #: Z-1347-2025

Product: DELIVERY PACK

Model / REF:

SGDV22D-01

SGDV22E

Lot Numbers:

70-051227

70-052347

UDI:

00191072223685

00191072230164

Recall #: Z-1348-2025

Product: LACERATION TRAY

Model / REF:

SGLA07A

SGLA07B-01

SGLA07B-02

SGLA07B

Lot Numbers:

899241

70-050880

70-051697

70-052161

70-052662

UDI:

00191072135063

00191072223715

Recall #: Z-1349-2025

Product: LACERATION TRAY

Model / REF:

SGLA07A

SGLA07B-01

SGLA07B-02

SGLA07B

Lot Numbers:

899241

70-050880

70-051697

70-052161

70-052662

UDI:

00191072135063

00191072223715

Recall #: Z-1350-2025

Product: EAR PACK

Model / REF:

SFEA12A

Lot Numbers:

968241

888241

70-052114

70-052727

70-053132

UDI:

00191072167446

Recall #: Z-1351-2025

Product: LAPAROSCOPY PACK

Model / REF:

SFLA02A

SFLA02B

Lot Numbers:

971241

947241

926241

894241

70-051029

70-051995

70-052417

70-052771

UDI:

00191072167491

00191072218698

Recall #: Z-1352-2025

Product: CV BASIC PUMP PACK

Model / REF:

WECV23D

Lot Numbers:

939241

71-050895

71-051582

71-052213

UDI:

00191072206664

Recall #: Z-1353-2025

Product: DIAGNOSTIC NEURO IR TRAY

Model / REF:

WENE21

Lot Numbers:

960241

71-050727

71-051234

71-051771

71-052322

71-052501

71-052705

UDI:

00191072212900

00191072218001

Recall #: Z-1354-2025

Product: NEURO IR TRAY

Model / REF:

WENI56J

Lot Numbers:

893241

71-051182

71-051813

UDI:

00191072217813

Recall #: Z-1355-2025

Product: AV FISTULA

Model / REF:

UTAV77T

Lot Numbers:

961241

890241

70-051326

70-051979

70-053058

UDI:

00191072205179

Recall #: Z-1356-2025

Product: GENERAL LAPAROSCOPIC PACK-LF

Model / REF:

UTGL53S-06

UTGL53S-07

UTGL53S-08

Lot Numbers:

941241

899241

70-050873

70-051230

70-051578

70-052009A

70-052884

UDI:

00191072147196

Recall #: Z-1357-2025

Product: MAJOR VASCULAR PACK

Model / REF:

UTMV78X-01

UTMV78Y

UTMV78Y-01

UTMV78Y-02

Lot Numbers:

974241

884241

70-051159

70-052011

70-052602

70-053158

UDI:

00191072205100

00191072217370

Recall #: Z-1358-2025

Product: OPEN HEART A PACK

Model / REF:

UTOH19AI

UTOH19AJ-01

UTOH19AJ-02

Lot Numbers:

921241

70-051173

70-052439

UDI:

00191072184450

00191072221070

Recall #: Z-1359-2025

Product: SPINE LUMBAR PACK

Model / REF:

UTSL72AA

UTSL72AB

Lot Numbers:

939241

88241

70-052063

70-052618A

70-053157

UDI:

00191072179753

Recall #: Z-1360-2025

Product: THORACIC PACK

Model / REF:

UTTC82Y

UTTC82AA-01

Lot Numbers:

954241

921241

889241

70-051283

70-052001

70-052096

70-053233

UDI:

00191072147332

Recall #: Z-1361-2025

Product: VEIN TRAY

Model / REF:

UTVT21C

UTVT21C02

UTVT21C-03

Lot Numbers:

70-051418

70-052083

70-052850

UDI:

00191072205193

Recall #: Z-1362-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96343

Status: Active

Manufacturer: American Contract Systems Inc

Sold By: American Contract Systems Inc

Manufactured In: United States

Units Affected: 32 products (303 kits; 1200 kits; 388 kits; 17 kits; 36 kits; 252 kits; 630 kits; 725 kits; 90 kits; 956 kits; 54 kits; 1106 kits; 1420; 1836 kits; 41 kits; 144 kits; 24 kits; 36 kits; 690 kits; 690 kits; 51 kits; 237 kits; 134 kits; 170 kits; 120 kits; 90 kits; 534 kits; 147 kits; 54 kits; 106 kits; 40 kits; 48 kits)

Distributed To: Ohio

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

Risk

What You Should Do

This recall affects dozens of surgical and medical procedure packs produced by American Contract Systems Inc, including Laparoscopy Packs, C-Section Packs, Labor & Delivery Packs, and various surgical trays.

Identify if you have the affected products by checking the model numbers, lot numbers, and Unique Device Identifiers (UDI) printed on the product labeling. See the Affected Products section below for the full list of affected codes.

Stop using the recalled surgical and medical packs immediately and quarantine any remaining stock to prevent further use in clinical procedures.

Contact American Contract Systems Inc or your authorized distributor to arrange for the return, replacement, or correction of the affected kits.

Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Affected Products

Product: LAPAROSCOPY PACK

Model / REF:

CALS41F

CALS41F-01

CALS41G

Lot Numbers:

962241

70-050280

70-050870

70-051556

70-052412

70-053051

UDI:

00191072215727

00191072233332

Recall #: Z-1331-2025

Product: DR DIULUS INJECTION PACK

Model / REF:

CCDU12C

CCDU12D

CCDU12D-01

Lot Numbers:

968241

70-050508

70-050945

70-051497

70-051882

70-052444

70-052967

UDI:

00191072196323

00191072229472

Recall #: Z-1332-2025

Product: HIP SCOPE

Model / REF:

CCHS21B

CCHS21B-01

CCHS21B-02

Lot Numbers:

962241

914241

70-050890

70-051579

70-052206

70-053085

UDI:

00191072193483

Recall #: Z-1333-2025

Product: MAJOR DIEP

Model / REF:

CCMJ73G-01

CCMJ73H

Lot Numbers:

879241

70-052915

UDI:

00191072222824

00191072223890

Recall #: Z-1334-2025

Product: CYSTO PACK

Model / REF:

HKCY31A

Lot Numbers:

933241

70-051382

70-052664

UDI:

00191072059093

Recall #: Z-1335-2025

Product: C-SECTION PACK

Model / REF:

LLCS44F

LLCS44F-01

Lot Numbers:

70-051011

70-051709

70-052452

70-052952

UDI:

00191072219107

Recall #: Z-1336-2025

Product: LAPAROSCOPY PACK

Model / REF:

LLLA21J

LLLA21J-02

Lot Numbers:

882241

70-051163

70-051373

70-051564

70-052582

70-053048

UDI:

00191072219206

Recall #: Z-1337-2025

Product: LABOR & DELIVERY PACK

Model / REF:

LLLD19H

Lot Numbers:

885241

70-051324

70-051967

70-052455

70-053006

UDI:

00191072219213

Recall #: Z-1338-2025

Product: OPEN HEART ADULT - SIDE A

Model / REF:

LLOH01I-01

LLOH01I

Lot Numbers:

898241

70-050704

70-051731

UDI:

00191072219251

Recall #: Z-1339-2025

Product: GENERAL ANGIO PACK

Model / REF:

LLAP75G

LLAP75G-01

LLAP75G-02

LLAP75G-03

Lot Numbers:

70-050850

70-051285

70-051779

70-051779A

70-052186

70-052669

70-053022

UDI:

00191072219510

Recall #: Z-1340-2025

Product: BORN ON ARRIVAL KIT

Model / REF:

LLBN11B

Lot Numbers:

891241

70-051710

70-052354

UDI:

00191072219558

Recall #: Z-1341-2025

Product: C-SECTION PPS

Model / REF:

LLCI66M

LLCI66M-02

LLCI66M-03

LLCI66M-04

Lot Numbers:

907241

70-050816

70-051301

70-051839

70-052420

70-052910

70-053100

UDI:

00191072219596

Recall #: Z-1342-2025

Product: CENTRAL LINE PICC

Model / REF:

LLCL44H

LLCL44H-01

Lot Numbers:

70-050707

70-050860

70-051149

70-051713

70-052363

70-053044

UDI:

00191072219602

Recall #: Z-1343-2025

Product: LABOR & DELIVERY PPS

Model / REF:

LLLD64O

LLLD64O-01

LLLD64O-02

Lot Numbers:

892241

70-051048

70-051516

70-052113

70-052313

70-052401

70-052911

UDI:

00191072219794

Recall #: Z-1344-2025

Product: URO ROBOTIC PACK

Model / REF:

LVUR44C

LVUR44C-03

Lot Numbers:

905241

70-050739

70-051020

70-051480

70-051606

70-051888

UDI:

00191072136688

Recall #: Z-1345-2025

Product: CYSTO

Model / REF:

SACY80R

Lot Numbers:

70-51139

70-052248

70-052564

70-052954

UDI:

00191072223425

Recall #: Z-1346-2025

Product: TOTAL HIP PACK

Model / REF:

SMTH06O

SMTH06P

Lot Numbers:

969241

928241

70-051508

70-052517

UDI:

00191072163882

00191072229601

Recall #: Z-1347-2025

Product: DELIVERY PACK

Model / REF:

SGDV22D-01

SGDV22E

Lot Numbers:

70-051227

70-052347

UDI:

00191072223685

00191072230164

Recall #: Z-1348-2025

Product: LACERATION TRAY

Model / REF:

SGLA07A

SGLA07B-01

SGLA07B-02

SGLA07B

Lot Numbers:

899241

70-050880

70-051697

70-052161

70-052662

UDI:

00191072135063

00191072223715

Recall #: Z-1349-2025

Product: LACERATION TRAY

Model / REF:

SGLA07A

SGLA07B-01

SGLA07B-02

SGLA07B

Lot Numbers:

899241

70-050880

70-051697

70-052161

70-052662

UDI:

00191072135063

00191072223715

Recall #: Z-1350-2025

Product: EAR PACK

Model / REF:

SFEA12A

Lot Numbers:

968241

888241

70-052114

70-052727

70-053132

UDI:

00191072167446

Recall #: Z-1351-2025

Product: LAPAROSCOPY PACK

Model / REF:

SFLA02A

SFLA02B

Lot Numbers:

971241

947241

926241

894241

70-051029

70-051995

70-052417

70-052771

UDI:

00191072167491

00191072218698

Recall #: Z-1352-2025

Product: CV BASIC PUMP PACK

Model / REF:

WECV23D

Lot Numbers:

939241

71-050895

71-051582

71-052213

UDI:

00191072206664

Recall #: Z-1353-2025

Product: DIAGNOSTIC NEURO IR TRAY

Model / REF:

WENE21

Lot Numbers:

960241

71-050727

71-051234

71-051771

71-052322

71-052501

71-052705

UDI:

00191072212900

00191072218001

Recall #: Z-1354-2025

Product: NEURO IR TRAY

Model / REF:

WENI56J

Lot Numbers:

893241

71-051182

71-051813

UDI:

00191072217813

Recall #: Z-1355-2025

Product: AV FISTULA

Model / REF:

UTAV77T

Lot Numbers:

961241

890241

70-051326

70-051979

70-053058

UDI:

00191072205179

Recall #: Z-1356-2025

Product: GENERAL LAPAROSCOPIC PACK-LF

Model / REF:

UTGL53S-06

UTGL53S-07

UTGL53S-08

Lot Numbers:

941241

899241

70-050873

70-051230

70-051578

70-052009A

70-052884

UDI:

00191072147196

Recall #: Z-1357-2025

Product: MAJOR VASCULAR PACK

Model / REF:

UTMV78X-01

UTMV78Y

UTMV78Y-01

UTMV78Y-02

Lot Numbers:

974241

884241

70-051159

70-052011

70-052602

70-053158

UDI:

00191072205100

00191072217370

Recall #: Z-1358-2025

Product: OPEN HEART A PACK

Model / REF:

UTOH19AI

UTOH19AJ-01

UTOH19AJ-02

Lot Numbers:

921241

70-051173

70-052439

UDI:

00191072184450

00191072221070

Recall #: Z-1359-2025

Product: SPINE LUMBAR PACK

Model / REF:

UTSL72AA

UTSL72AB

Lot Numbers:

939241

88241

70-052063

70-052618A

70-053157

UDI:

00191072179753

Recall #: Z-1360-2025

Product: THORACIC PACK

Model / REF:

UTTC82Y

UTTC82AA-01

Lot Numbers:

954241

921241

889241

70-051283

70-052001

70-052096

70-053233

UDI:

00191072147332

Recall #: Z-1361-2025

Product: VEIN TRAY

Model / REF:

UTVT21C

UTVT21C02

UTVT21C-03

Lot Numbers:

70-051418

70-052083

70-052850

UDI:

00191072205193

Recall #: Z-1362-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96343

Status: Active

Manufacturer: American Contract Systems Inc

Sold By: American Contract Systems Inc

Manufactured In: United States

Distributed To: Ohio