Skip to content
Get alerts
GovInfoNow
Unrated Medical device recall · FDA · Published September 24, 2020

Zimmer Biomet Hip Cup Recall: Unconfirmed Sterilant Risk

Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include specific cup models sold globally. Consumers should contact manufacturer for details.

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

🇺🇸 FDA recall #Z-0344-2021Medical deviceZimmer Biomet ›
Take action

Contact the company

Recalling firmZimmer Biomet, Inc.1800 W Center St · Warsaw, IN 46580-2304
✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling hip replacement cups that may have unconfirmed risks from residual sterilant. This could potentially cause adverse tissue reactions, though the exact risk level isn't confirmed. Read more at govinfonow.com/recall/64147-zimmer-biomet-hip-cup-recall-unconfirmed-sterilant-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64147-zimmer-biomet-hip-cup-recall-unconfirmed-sterilant-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0344-2021

Cite this page

“Zimmer Biomet Hip Cup Recall: Unconfirmed Sterilant Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64147-zimmer-biomet-hip-cup-recall-unconfirmed-sterilant-risk. Based on FDA recall #Z-0344-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0344-2021%22&limit=1).

The FDA announced on 2020-09-24 that Zimmer Biomet, Inc. voluntarily recalled ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene components due to unaevaluated residual sterilant posing a potential for adverse tissue reactions. The agency issued recall number Z-0344-2021 for the Class II device distributed nationwide.

How to tell if you have it

  • Brand: Zimmer Biomet
  • Product: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm
  • Item Number: 00-8065-552-32
  • Lots: All lots
  • Units affected: 412 units total

The hazard

The sterilant (hydrogen peroxide) used in the acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. This raises the potential for adverse tissue reactions, according to the FDA.

Context

GovInfoNow's records show Zimmer Biomet, Inc. has had 94 other recalls on record since 2017-06-05. Other recent recalls of similar products include Medline Recalls Knee Surgery Kits Due to Sterility Risk (2026-06-10), Zimmer Sterile Tourniquet Hoses Recall: Sterility Breach Risk (2026-06-09), and AVID Medical Haylard Basic Biopsy Tray Recall: Sterility Risk (2026-08-10).

How to tell if you have this one

Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 32 mm internal diameter, and the item number 00-8065-552-32. All lots of this product are affected.

  • Brand
    Zimmer Biomet
  • Category
    Medical device
FDA recall event · 75 products

All 75 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
    Terminated
  • Distribution
    US Nationwide
Recall numberProduct, codes & lotsQuantity
Z-0323-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-540-22 Hip prosthesis component; All lots412 units total
Z-0324-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-22 Hip prosthesis component; All lotsN/A
Z-0325-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-26 Hip prosthesis component; All lots412 units total
Z-0326-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-22; All lots412 units total
Z-0327-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-26; All lots412 units total
Z-0328-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-28; All lots412 units total
Z-0329-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-22; All lots412 units total
Z-0330-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-26; All lots412 units total
Z-0331-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-28; All lots412 units total
Z-0332-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-32; All lots412 units total
Z-0333-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-22; All lots412 unit total
Z-0334-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-26; All lots412 units total
Z-0335-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-28; All lots412 units total
Z-0336-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-32; All lots412 units total
Z-0337-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-22; All lots412 units total
Z-0338-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-26; All lots412 units total
Z-0339-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-28; All lots412 units Total
Z-0340-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-32; All lots412 units total
Z-0341-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-22; All lots412 units total
Z-0342-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-26; All lots412 units total
Z-0343-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-28; All lots412 units total
Z-0344-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-32; All lots412 units total
Z-0345-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 57 mm Item Number: 00-8065-554-22; All lots412 units total
Z-0346-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26; All lots412 units total
Z-0347-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-28; All lots412 units total
Z-0348-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32; All lots412 units total
Z-0349-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-22; All lots412 units total
Z-0350-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-26; All lots412 unit total
Z-0351-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-28; All lots412 units total
Z-0352-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-32; All lots412 units total
Z-0353-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-22; All lots412 units total
Z-0354-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26; All lots412 units total
Z-0355-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-28; All lots412 units total
Z-0356-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-32; All lots412 units total
Z-0357-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 43 mm Number: 00-8065-640-22; All lots412 units total
Z-0358-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 00-8065-642-22; All lots412 units total
Z-0359-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 00-8065-642-26; All lots412 units Total
Z-0360-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-22; All lots412 units total
Z-0361-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-26; All lots412 units total
Z-0362-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-28; All lots412 units total
Z-0363-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-22; All lots412 units total
Z-0364-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-26; All lots412 units total
Z-0365-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-28; All lots412 units total
Z-0366-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-32; All lotsN/A
Z-0367-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-22; All lots412 units total
Z-0368-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-26; All lots412 units total
Z-0369-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-28; All lotsN/A
Z-0370-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-32; All lotsN/A
Z-0371-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-22; All lots412 units total
Z-0372-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-26; All lots412 units total
Z-0373-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-28; All lots412 units total
Z-0374-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-32; All lots412 units total
Z-0375-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-22; All lots412 units total
Z-0376-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-26; All lots412 units total
Z-0377-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-28; All lots412 units total
Z-0378-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-32; All lots412 units total
Z-0379-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-22; All lots412 units total
Z-0380-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-26; All lots412 units total
Z-0381-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-28; All lots412 units total
Z-0382-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-32; All lots412 units total
Z-0383-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-22; All lots412 units total
Z-0384-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-26; All lots412 units total
Z-0385-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-28; All lots412 units total
Z-0386-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-32; All lots412 units total
Z-0387-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-22; All lots412 units total
Z-0388-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-26; All lots412 units total
Z-0389-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-28; All lots412 units total
Z-0390-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-32; All lots412 units total
Z-0391-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 49 mm Number: 00-8065-946-32; All lots412 units total
Z-0392-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 51mm Number: 00-8065-948-32; All lots412 units total
Z-0393-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 53 mm Number: 00-8065-950-32; All lots412 units total
Z-0394-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm Number: 00-8065-952-32; All lots412 units total
Z-0395-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 57 mm Number: 00-8065-954-32; All lots412 units total
Z-0396-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm Number: 00-8065-956-32; All lots412 units total
Z-0397-2021ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 61 mm Number: 00-8065-958-32; All lots412 units total
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Zimmer Biomet directly for specific instructions on how to handle the recalled item.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Sep 24, 202012. FDA classified it Class II: Nov 2, 202023. Published in FDA’s Enforcement Report: Nov 11, 202034. FDA terminated the recall: May 20, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0344-2021 (September 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0344-2021 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