Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published August 7, 2024

American Contract Systems Pacemaker Recall: Humidity Issues Affect Sterilization

American Contract Systems recalls Pacemaker COPM11B medical kits due to humidity readings causing sterilization concerns. Affected units have specific lot and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3244-2024Medical deviceAmerican Contract Systems ›
Take action

Contact the company

Recalling firmAmerican Contract Systems, Inc.2610 Ne Industrial Dr Ste 220 · Kansas City, MO 64117-2648
✎ GovInfoNow plain-language explainer

American Contract Systems is recalling Pacemaker COPM11B medical kits because humidity readings in one controlled area may mean the products weren't properly sterilized. This could affect medical safety if used without proper sterilization. Read more at govinfonow.com/recall/54271-american-contract-systems-pacemaker-recall-humidity-issues-affect-sterilization.

Source Summary by GovInfoNow · govinfonow.com/recall/54271-american-contract-systems-pacemaker-recall-humidity-issues-affect-sterilization · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3244-2024

Cite this page

“American Contract Systems Pacemaker Recall: Humidity Issues Affect Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54271-american-contract-systems-pacemaker-recall-humidity-issues-affect-sterilization. Based on FDA recall #Z-3244-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3244-2024%22&limit=1).

The FDA announced on August 7, 2024, that American Contract Systems Inc. is recalling one Pacemaker, COPM11B; Medical convenience kit due to an inoperable chart recorder. This defect caused humidity readings to be out-of-specification, preventing the company from confirming product sterilization assurance requirements were met.

How to tell if you have it

  • Brand: American Contract Systems
  • Product: Pacemaker, COPM11B; Medical convenience kit
  • UDI-DI: 00191072206312
  • Lot: 2405033
  • Expiration: 05/03/2025
  • Quantity: 3 units

The hazard

According to the FDA, American Contract Systems identified that an inoperable chart recorder resulted in humidity readings being out-of-specification in one of the controlled environment areas. As a result, the company is unable to confirm product sterilization assurance requirements were met.

Context

GovInfoNow's records show American Contract Systems Inc has had 21 other recalls on record since November 21, 2018. Other recent recalls of similar products include Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 (August 10, 2026), Convenience Kits with catheters that may not meet performance specs (June 29, 2026), and Medical kits with endotoxin variability risk (May 19, 2026). Other recent recalls of similar products include Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (January 7, 2026) and Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (January 7, 2026).

How to tell if you have this one

Check for the lot number 2405033 and expiration date 05/03/2025 on the Pacemaker COPM11B medical kits. The product is sold under the brand American Contract Systems.

  • Brand
    American Contract Systems
  • Category
    Medical device
FDA recall event · 19 products

All 19 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Recall numberProduct, codes & lotsQuantity
Z-3226-2024PACEMAKER PACK, SLCV01J; Medical convenience kit; UDI-DI: 00191072213846; Lot: 2405112; Exp: 05/11/202520 units
Z-3227-2024Endovascular AAA Pack, ESED52B; Medical convenience kit; UDI-DI: 00191072218339; Lot: 2405153; Exp: 05/15/202593 units
Z-3228-2024Endovascular AAA Pack, ESED52B; Medical convenience kit; UDI-DI: 00191072198402; Lot: 2405152; Exp: 05/15/2025360 units
Z-3229-2024Arthroscopy Pack, MSKA45A; Medical convenience kit; UDI-DI: 00191072200938; Lot: 2405153; Exp: 05/15/202548 units
Z-3230-2024Open Shoulder, LWOS39L; Medical convenience kit; UDI-DI: 00191072177032; Lot: 2405141; Exp: 05/14/202512 units
Z-3231-2024Day Surgery General Pack, FHGE18T; Medical convenience kit; UDI-DI: 00191072210517; Lot: 2405131; Exp: 05/13/2025280 units
Z-3232-2024Shoulder, SESH18I; Medical convenience kit; UDI-DI: 00191072198532; Lot: 2405112; Exp: 05/11/202560 units
Z-3233-2024Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit; UDI-DI: 00191072178107; Lot: 2405102; Exp: 05/10/202518 units
Z-3234-2024Paracentesis Thoracente, SLPT76H; Medical convenience kit; UDI-DI: 00191072199065; Lot: 2405102; Exp: 05/10/2025504 units
Z-3235-2024IR Procedure Pack, CEAT19W; Medical convenience kit; UDI-DI: 00191072184566; Lot: 2405102; Exp: 05/10/20241 unit
Z-3236-2024Neuro Vascular, ANKV91A; Medical convenience kit; UDI-DI: 00191072201232; Lot: 2405102; Exp: 05/10/20251 unit
Z-3237-2024Hand Pack, AKHD97C; Medical convenience kit; UDI-DI: 00191072217660; Lot: 2405102; Exp: 05/10/20252 units
Z-3238-2024Vaginal Delivery, ASDV25B; Medical convenience kit; UDI-DI: 00191072218841; Lot: 2405102; Exp: 05/10/20251 unit
Z-3239-2024Cath Lab Pack, CECL02P; Medical convenience kit; UDI-DI: 00191072206497; Lot: 2405102; Exp: 05/10/20251 unit
Z-3240-2024Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit; UDI-DI: 00191072218438; Lot: 2405102; Exp: 05/10/202568 units
Z-3241-2024ENT, COEN27N; Medical convenience kit; UDI-DI: 00191072206244; Lot: 2405092; Exp: 05/09/202566 units
Z-3242-2024Nasal Sinus Pack, MTSN26B; Medical convenience kit; UDI-DI: 00191072200242; Lot: 2405093; Exp: 05/09/202557 units
Z-3243-2024Cysto, FTCY03L; Medical convenience kit; UDI-DI: 00191072189295; Lot: 2405033; Exp: 05/03/202536 units
Z-3244-2024Pacemaker, COPM11B; Medical convenience kit; UDI-DI: 00191072206312; Lot: 2405033; Exp: 05/03/20253 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for lot number 2405033 and expiration date 05/03/2025 on the Pacemaker COPM11B medical kits.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of MO, MN, MA, OH, NE.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Massachusetts, Minnesota, Missouri, Nebraska, Ohio.

Recall timeline

FDA published this recall 56 days after the firm started it.

1. Firm started the recall: Aug 7, 202412. FDA classified it Class II: Sep 24, 202423. Published in FDA’s Enforcement Report: Oct 2, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3244-2024 (August 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3244-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA