ModerateClass IITerminated

FDA Devices recall · Reported October 21, 2020

AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 21, 2020. Severity: Moderate. Recall number: Z-0098-2021.

Q: Where was the recalled product distributed?

Distribution: US distribution to DE, NC, OK, PA, and TX..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0098-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connection…

Recall #: Z-0098-2021
Affected scope: 15 units
Initiated: September 1, 2020

Compiled from official public sources by the editorial team. · Updated July 2026

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Fresenius Medical Care Holdings, Inc. recalled AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system… - a moderate-severity action.

AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system… was recalled by Fresenius Medical Care Holdings, Inc. in October 21, 2020. Reason: Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If th…. Check the official notice for the remedy. Verify recall #Z-0098-2021 with the FDA Devices before acting.

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The recall

Fresenius Medical Care Holdings, Inc. issued this moderate-severity FDA Devices recall-Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If th….

Moderate
severity level: 15 units
affected scope: Class II
classification: October 21, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0098-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0098-2021) was formally reported on October 21, 2020, with the manufacturer initiating the action on September 1, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Fresenius Medical Care Holdings, Inc. is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 15 units.

The documented reason for this recall is: Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely a… Distribution data in the federal record shows the product reached: US distribution to DE, NC, OK, PA, and TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

15 units

Related Recalls

3 from same agency

Product description

AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0

Reason for recall

Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0098-2021
Date reported	October 21, 2020
Date initiated	September 1, 2020
Recalling firm	Fresenius Medical Care Holdings, Inc.
Firm location	Waltham, MA
Affected scope	15 units
Distribution	US distribution to DE, NC, OK, PA, and TX.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

15 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0098-2021) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 21, 2020. Severity: Moderate. Recall number: Z-0098-2021.

Where was the recalled product distributed? ▼

Distribution: US distribution to DE, NC, OK, PA, and TX..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0098-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 21, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.