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Recall Observatory FDA recall evidence

Current FDA corpus

Search recall evidence

Search official identifiers, recalled products, recalling firms, recall reasons, distribution language, and available device root-cause evidence.

Ordinary terms are combined with AND. Put a literal phrase in quotation marks. Raw operators, wildcards, field syntax, and repeated controls are rejected.

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Results for “"root cause"”

112 true results · 25 per page

Events
28
Products
56
Firms
28

Events

28 true total · 8 on this page

Recall event

Event 92290

92290
Matched recall reason

Recall reason · … Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and …

Represented date
August 01, 2023
Product type
Device
Classification
Class II
Matching products
2

Recall event

Event 78096

78096
Matched recall reason

Recall reason · … We have identified the root cause as a supplied component that was not to specification. If the strap …

Represented date
September 08, 2017
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 73357

73357
Matched recall reason

Recall reason · … Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm …

Represented date
February 18, 2016
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 65356

65356
Matched recall reason

Recall reason · … Based on extensive root cause investigation, it has been determined that the leakage is the result of a …

Represented date
April 04, 2013
Product type
Device
Classification
Class II
Matching products
2

Recall event

Event 95439

95439
Matched recall reason

Recall reason · … During further root cause testing and investigation, an additional 6 devices were found to produce false negative test …

Represented date
August 23, 2024
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 67503

67503
Matched recall reason

Recall reason · … was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result …

Represented date
February 25, 2014
Product type
Device
Classification
Class II
Matching products
15

Recall event

Event 72038

72038
Matched recall reason

Recall reason · … Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014 …

Represented date
August 18, 2015
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 76828

76828
Matched recall reason

Recall reason · … Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of …

Represented date
March 23, 2017
Product type
Device
Classification
Class II
Matching products
1

Products

56 true total · 9 on this page

Z-1090-2016
Matched recall reason

Recall reason · … Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm …

Represented date
February 18, 2016
Product type
Device
Classification
Class II
Z-0259-2025
Matched recall reason

Recall reason · … During further root cause testing and investigation, an additional 6 devices were found to produce false negative test …

Represented date
August 23, 2024
Product type
Device
Classification
Class II

Firms

28 true total · 8 on this page

skytron llc
Matched recall reason

Recall reason · … Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and …

Represented date
August 01, 2023
Product type
Device
Classification
Class II
Matching products
2
handicare usa inc
Matched recall reason

Recall reason · … We have identified the root cause as a supplied component that was not to specification. If the strap …

Represented date
September 08, 2017
Product type
Device
Classification
Class II
Matching products
1

FDA name variants: Handicare Usa Inc · Handicare USA, Inc.

tem systems inc
Matched recall reason

Recall reason · … Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm …

Represented date
February 18, 2016
Product type
Device
Classification
Class II
Matching products
1
b braun medical inc
Matched recall reason

Recall reason · … Based on extensive root cause investigation, it has been determined that the leakage is the result of a …

Represented date
April 04, 2013
Product type
Device
Classification
Class II
Matching products
2

FDA name variants: B. Braun Medical, Inc. · B Braun Medical Inc · B BRAUN MEDICAL INC

princeton biomeditech corp
Matched recall reason

Recall reason · … During further root cause testing and investigation, an additional 6 devices were found to produce false negative test …

Represented date
August 23, 2024
Product type
Device
Classification
Class II
Matching products
1
zimmer inc
Matched recall reason

Recall reason · … was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result …

Represented date
February 25, 2014
Product type
Device
Classification
Class II
Matching products
15

FDA name variants: Zimmer, Inc. · Zimmer Inc.

zien medical technologies inc
Matched recall reason

Recall reason · … Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014 …

Represented date
August 18, 2015
Product type
Device
Classification
Class II
Matching products
1
sysmex america inc
Matched recall reason

Recall reason · … Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of …

Represented date
March 23, 2017
Product type
Device
Classification
Class II
Matching products
1

FDA name variants: Sysmex America, Inc. · Sysmex America Inc