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Lower risk Medical device recall · FDA · Published September 3, 2020

Allison Medical CarePoint 6: Syringe Without Needle May Have Unknown Substance

Allison Medical recalls CarePoint 60 mL syringes without needles that may have a green substance on the plunger. The substance is nontoxic but its effect on drug potency is unknown.

🇺🇸 FDA recall #Z-0478-2023Medical deviceAllison Medical ›
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Recalling firmAllison Medical, Inc.8091 Shaffer Pkwy · Littleton, CO 80127-3716
✎ GovInfoNow plain-language explainer

Allison Medical is recalling CarePoint 60 mL syringes without needles that may have a green substance on the plunger. This substance is nontoxic but its effect on drug potency is unknown, so users should check if they have the recalled model. Read more at govinfonow.com/recall/64380-allison-medical-carepoint-6-syringe-without-needle-may-have-unknown.

Source Summary by GovInfoNow · govinfonow.com/recall/64380-allison-medical-carepoint-6-syringe-without-needle-may-have-unknown · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0478-2023

Cite this page

“Allison Medical CarePoint 6: Syringe Without Needle May Have Unknown Substance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64380-allison-medical-carepoint-6-syringe-without-needle-may-have-unknown. Based on FDA recall #Z-0478-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0478-2023%22&limit=1).

The FDA announced on Sept. 3, 2020, that Allison Medical, Inc. is recalling CarePoint 60 mL Syringes Without Needle due to a green substance on the plunger. The agency issued recall number Z-0478-2023 for the voluntary Class II action.

How to tell if you have it

  • Brand: Allison Medical
  • Product: CarePoint 60 mL Syringe Without Needle
  • REF: 04-7560
  • UDI-DI: 00786227756059
  • Lot: 80522
  • Quantity: 2,004 Boxes

The hazard

The syringes may have a green substance on the plunger. The FDA stated that while the substance is nontoxic, its effect on drug potency or interaction is unknown.

Context

GovInfoNow's records show Allison Medical, Inc. has one other recall on record since Jan. 19, 2018, involving InControl Insulin Syringes for incorrect labeling. Other recent recalls of similar products include Medline Convenience Kits with Unapproved Syringes Recalled (Feb. 27, 2026), Medline Convenience Kits with Unapproved Syringes: Safety Recall (Feb. 27, 2026), and Medline Convenience Kits with Unapproved Syringes: Recall for Design Changes (Feb. 27, 2026).

How to tell if you have this one

Check for the CarePoint 60 mL syringe without needle with reference number 04-7560. The product was sold with UDI-DI: 00786227756059 and lot number 80522.

  • Brand
    Allison Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Green Substance

    Inspect the plunger for a green substance. If present, stop using the syringe.

Where it went and when

Where it was distributed

Distributed in 4 states and Puerto Rico.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: yesMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “US: IA, LA, MS, FL, PR; OUS: BARBADOS” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Iowa, Louisiana, Mississippi, Puerto Rico.

Recall timeline

FDA published this recall 2.3 years after the firm started it.

1. Firm started the recall: Sep 3, 202012. FDA classified it Class II: Dec 13, 202223. Published in FDA’s Enforcement Report: Dec 21, 2022320202022
  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.

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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-0478-2023 (September 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0478-2023 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