Medical DeviceApr 10, 2024
SleepNet Mojo 2 Full Face AAV Non Vented Mask, All Sizes recall — FDA Z-1355-2024
Update to contraindications and warning language due to CPAP masks containing magnets.
Class IFDA: OngoingSleepNet Corporation
April 2024 recalls — page 11
These records include useful source details for the selected month.
Medical DeviceApr 10, 2024
MEDLINE INDUSTRIES, LP - Northfield Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code recall — FDA Z-1429-2024
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
Abbott GmbH ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 recall — FDA Z-1479-2024
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead…
Class IIFDA: OngoingAbbott GmbH
Medical DeviceApr 10, 2024
Life Technologies Torrent Suite Dx Software versions 5.14 and earlier used in connection recall — FDA Z-1426-2024
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings,…
Class IIFDA: OngoingLife Technologies Corporation
Medical DeviceApr 10, 2024
MEDLINE INDUSTRIES, LP - Northfield Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300) recall — FDA Z-1451-2024
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT recall — FDA Z-1470-2024
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class IIFDA: OngoingCovidien, LP
Medical DeviceApr 10, 2024
MEDLINE INDUSTRIES, LP - Northfield Centurion manual surgical kits labeled as: a) STERILE recall — FDA Z-1444-2024
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY recall — FDA Z-1409-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
FoodApr 10, 2024
THE COCA-COLA COMPANY Powerade Zero Mixed Berry - 20 oz PET bottles 24 pack, 8 recall — FDA F-1111-2024
The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
Class IIFDA: TerminatedTHE COCA-COLA COMPANY
FoodApr 10, 2024
Turkana Food Sekeroglu Lokum Love Turkish Delight With Pistachio And recall — FDA F-1119-2024
Product contains Acid Red 18
Class IIFDA: TerminatedTurkana Food Inc.
FoodApr 10, 2024
AJI MORI SAUCE AJI MORI***CHILLIMAMI SAUCE***UMAMI BOMB***NET WT recall — FDA F-1115-2024
Potential contamination with Clostridium botulinum
Class IIFDA: TerminatedAJI MORI SAUCE CORP
FoodApr 10, 2024
Kick Ash Products Door County Love Dark Chocolate Cherry Granola, 1lb, laminated recall — FDA F-1116-2024
Undeclared allergen (almond) in Dark Chocolate Cherry Granola
Class IFDA: TerminatedKick Ash Products LLC
FoodApr 10, 2024
Turkana Food Sekeroglu Lokum Love Turkish Delight Mixed With Pistachio And recall — FDA F-1118-2024
Product contains Acid Red 18
Class IIFDA: TerminatedTurkana Food Inc.
FoodApr 10, 2024
Waiakea Hawaiian Volcanic Water Naturally Alkaline recall — FDA F-1117-2024
Consumer complaints involving floating particles.
Class IIFDA: TerminatedWaiakea Bottling Inc.
FoodApr 10, 2024
THE COCA-COLA COMPANY Powerade Zero Fruit Punch - 20oz PET bottles 24 pack, 8 recall — FDA F-1112-2024
The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
Class IIFDA: TerminatedTHE COCA-COLA COMPANY
FoodApr 10, 2024
Samsung Bean Sprout Soy Bean Sprouts in a package labeled in part: Sam Sung Soy recall — FDA F-1114-2024
Listeria monocytogenes.
Class IFDA: TerminatedSamsung Bean Sprout
FoodApr 10, 2024
THE COCA-COLA COMPANY Powerade Mountain Berry Blast - 20oz PET bottles 24 pack, 8 recall — FDA F-1113-2024
The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
Class IIFDA: TerminatedTHE COCA-COLA COMPANY
DrugApr 10, 2024
X-Gen Pharmaceuticals Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized recall — FDA D-0433-2024
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted…
Class IIIFDA: TerminatedX-Gen Pharmaceuticals Inc.
DrugApr 10, 2024
SSM Health Care St. Louis DBA SSM St. Clare FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride recall — FDA D-0436-2024
Lack of Assurance of Sterility: Firm did not perform process validation.
Class IIFDA: OngoingSSM Health Care St. Louis DBA SSM St. Clare Health…
DrugApr 10, 2024
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 recall — FDA D-0430-2024
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Class IIFDA: OngoingGlenmark Pharmaceuticals Inc., USA
DrugApr 10, 2024
X-Gen Pharmaceuticals Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose recall — FDA D-0434-2024
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted…
Class IIIFDA: TerminatedX-Gen Pharmaceuticals Inc.
DrugApr 10, 2024
SSM Health Care St. Louis DBA SSM St. Clare Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total recall — FDA D-0435-2024
Lack of Assurance of Sterility: Firm did not perform process validation.
Class IIFDA: OngoingSSM Health Care St. Louis DBA SSM St. Clare Health…
Medical DeviceApr 3, 2024
Hologic Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and recall — FDA Z-1371-2024
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceApr 3, 2024
InfuTronix Nimbus II Infusion System recall — FDA Z-1286-2024
InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product…
Class IFDA: OngoingInfuTronix LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.