DrugDec 6, 2023
Paroxetine Hydrochloride Tablets USP recall — FDA D-0120-2024
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class IIFDA: OngoingApotex Corp.
Monthly breakdown
2023 recalls by month
Select a month to review the recall records reported during that period.
December 2023295 records · 4 categoriesNovember 2023387 records · 4 categoriesOctober 2023214 records · 4 categoriesSeptember 2023253 records · 4 categoriesAugust 2023478 records · 4 categoriesJuly 2023263 records · 4 categoriesJune 2023339 records · 4 categoriesMay 2023410 records · 4 categoriesApril 2023189 records · 4 categoriesMarch 2023788 records · 4 categoriesFebruary 2023253 records · 4 categoriesJanuary 2023205 records · 4 categories
2023 recalls — page 13
Records are ordered by the best available source date.
DrugDec 6, 2023
Botanical Be Artri King Reforzado con Origa y Omega 3 tablets recall — FDA D-0224-2024
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class IFDA: OngoingBotanical Be
DrugDec 6, 2023
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30 recall — FDA D-0130-2024
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Class IIFDA: TerminatedGolden State Medical Supply Inc.
DrugDec 6, 2023
Paroxetine Hydrochloride Tablets USP recall — FDA D-0119-2024
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class IIFDA: OngoingApotex Corp.
DrugDec 6, 2023
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30 recall — FDA D-0128-2024
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Class IIFDA: TerminatedGolden State Medical Supply Inc.
DrugDec 6, 2023
Paroxetine Hydrochloride Tablets USP recall — FDA D-0121-2024
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class IIFDA: OngoingApotex Corp.
VehicleDec 6, 2023
BMW control module (tcm/pcm/tecm) recall — NHTSA campaign 23V821000
BMW of North America, LLC (BMW) is recalling certain 2023 Toyota GR Supra, 3 Series Sedan (330i xDrive, M340i xDrive, M3), 5 Series Sedan (530i, 530i xDrive, M5), 4 Series Gran Coupe (430i,…
control module (tcm/pcm/tecm)BMW of North America, LLC
Medical DeviceNov 29, 2023
Aizu Olympus Co Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the recall — FDA Z-0348-2024
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes…
Class IIFDA: OngoingAizu Olympus Co., Ltd.
Medical DeviceNov 29, 2023
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038 recall — FDA Z-0360-2024
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the…
Class IIFDA: OngoingAvanos Medical, Inc.
Medical DeviceNov 29, 2023
SunMed Holdings Ventlab, LLC RescuMed manual resuscitators with integrated manometer recall — FDA Z-0364-2024
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIFDA: OngoingSunMed Holdings, LLC
Medical DeviceNov 29, 2023
Biomet Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of recall — FDA Z-0377-2024
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Class IIFDA: OngoingBiomet, Inc.
Medical DeviceNov 29, 2023
Medtronic Neuromodulation Model 97745 Controller used with Models 97715 and 97716 Intellis recall — FDA Z-0354-2024
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Class IIFDA: OngoingMedtronic Neuromodulation
Medical DeviceNov 29, 2023
Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose recall — FDA Z-0359-2024
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceNov 29, 2023
Sentinel CH SpA Alinity c Iron Reagent, Reference Number 08P3920 recall — FDA Z-0326-2024
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron…
Class IIFDA: OngoingSentinel CH SpA
Medical DeviceNov 29, 2023
Unomedical A/S VariSoft infusion set, Model Number 1002830 recall — FDA Z-0234-2024
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector…
Class IFDA: OngoingUnomedical A/S
Medical DeviceNov 29, 2023
Biomet Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful recall — FDA Z-0382-2024
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Class IIFDA: OngoingBiomet, Inc.
Medical DeviceNov 29, 2023
Biomet Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of recall — FDA Z-0373-2024
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Class IIFDA: OngoingBiomet, Inc.
Medical DeviceNov 29, 2023
BioFire Diagnostics FilmArray TORCH REF HTFA-ASY-0104 recall — FDA Z-0353-2024
Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceNov 29, 2023
Philips Intera 1.5T recall — FDA Z-0393-2024
Potential component failure in the Gradient Coil could product smoke and/or fire.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceNov 29, 2023
Philips Intera 1.5T Power/Pulsar recall — FDA Z-0394-2024
Potential component failure in the Gradient Coil could product smoke and/or fire.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceNov 29, 2023
Biomet Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of recall — FDA Z-0376-2024
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Class IIFDA: OngoingBiomet, Inc.
Medical DeviceNov 29, 2023
Aizu Olympus Co Hysteroscope-For endoscopic diagnosis within the uterus recall — FDA Z-0335-2024
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes…
Class IIFDA: OngoingAizu Olympus Co., Ltd.
Medical DeviceNov 29, 2023
Aizu Olympus Co Mobile airway scope-diagnosis and observation to access airway anatomy recall — FDA Z-0340-2024
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes…
Class IIFDA: OngoingAizu Olympus Co., Ltd.
Medical DeviceNov 29, 2023
Biomet Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful recall — FDA Z-0383-2024
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Class IIFDA: OngoingBiomet, Inc.
About the 2023 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.