Current FDA corpus

Search recall evidence

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

Product, firm, identifier, or evidence phrase

Result scope

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

Recalled product

GS70H Salus Surgical Table, Product Code 18-071-70

Z-2470-2023

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

Recalled product

PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

Z-0013-2018

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

Recalled product

ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

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

Recalled product

13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

Z-0425-2014

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

Recalled product

20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

Z-0424-2014

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

Recalled product

Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004

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

Recalled product

Apollo" Knee System: APOLLO PATELLA SZ0 28MM R

Z-1258-2014

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

Recalled product

PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15

Z-2800-2015

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

Recalled product

Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan

Z-2034-2017

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

Firms

28 true total · 8 on this page

Firm

Skytron, LLC

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

Firm

Handicare Usa Inc

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.

Firm

TEM Systems 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

Firm

B. Braun Medical, Inc.

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

Firm

Princeton Biomeditech Corp

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

Firm

Zimmer, Inc.

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.

Firm

Zien Medical Technologies, 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

Firm

Sysmex America, Inc.

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