Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
28,065 detailed records are currently available in this category.
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds…
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due…
Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x…
A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due…
An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit…
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds…
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds…
PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable…
Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could…
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to…
Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump…
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was…
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
