STERIS Sterilization Indicators Recalled Due to Temperature Excursions
Six sterilization monitoring devices from STERIS Corporation were recalled due to temperature excursions during storage and delivery that may have compromised their effectiveness. Affected products were distributed nationwide between June and September 2021.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class III recall involves a theoretical hazard with no reported illnesses or injuries. The concern is potential loss of sterilization indicator effectiveness due to thermal exposure during storage and shipment, representing a voluntary precautionary measure rather than confirmed harm or agency classification at Class I or II level.
Plain-English summary
Six sterilization indicator and biological indicator products from STERIS Corporation manufactured and distributed by Mckesson Medical-Surgical Inc. are being recalled. The recalled products are: Celerity 20 Sterilization Indicator Challenge Pack (Model LCB053), Verify Sterilization Flash Indicator Strip (Model PCC006), Verify Sterilization Biological Indicator Pack (Model S3069), Celerity Sterilization Biological Indicator Vial (Model LCB044), Celerity 20 Sterilization Indicator Challenge Pack (Model LCB049), and Verify Sterilization Indicator Challenge Pack (Model LCB035).
The recall was initiated due to facility temperature excursions that occurred between June and August 2021 prior to delivery. Exposure to higher temperatures during storage and shipment may have impacted the effectiveness of these sterilization monitoring devices. All products with lot codes received between June 1, 2021 and September 30, 2021 are affected.
The affected products were distributed nationwide. Healthcare facilities and individuals who received these sterilization indicators should contact the manufacturer or distributor if they have questions about whether their products are affected. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biol
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- thermal-damage
- sterilization-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- GTIN: a. 00724995161569
- 10724995161566. b. 00724995084653
- 10724995084650. c. 00724995023867
- 10724995023864. d. 00724995154233
- 10724995154230. e. 00724995161552
- 10724995161559. f. 00724995002558.
Distribution
Distributed nationwide across the United States.
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