FoodMay 12, 2021
Natrol Tab 60 White bottle with purple flip-top cap recall — FDA F-0479-2021
One lot of ALA 300 mg Cap-50 were labeled at Melatonin 3 mg Tab-60.
Class IIFDA: TerminatedNatrol, LLC
Latest records
Latest recalls — page 875
The newest recall records with useful source details are listed here.
FoodMay 12, 2021
Forest Mushroom Food Guan's Enoki Mushroom - Champigons d'enoki recall — FDA F-0476-2021
Michigan Department of Agriculture and Rural Development sampled Enoki mushrooms and found some samples to be positive for Listeria monocytogenes.
Class IFDA: TerminatedForest Mushroom Food Inc.
FoodMay 12, 2021
JKH Enterprises Granny's Fudge Gorgeous Peanut Brittle, net wt recall — FDA F-0491-2021
Ingredients statement declares Unsalted Cream but does not list milk. Label has allergen advisory statement "Mfg on same equipment that processes wheat, egg, peanut & tree nut. May contain…
Class IIFDA: TerminatedJKH Enterprises
DrugMay 12, 2021
PNHC, LLC heal the world, moisturizing original hand sanitizer, Non-Sterile Solution recall — FDA D-0365-2021
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class IFDA: TerminatedPNHC, LLC.
DrugMay 12, 2021
ACETAMINOPHEN recall — FDA D-0358-2021
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label…
Class IFDA: TerminatedA-S Medication Solutions LLC.
Medical DeviceMay 5, 2021
Luminex VERIGENE Processor SP - Product Usage: intended for processing and identifying recall — FDA Z-1488-2021
Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Class IIFDA: OngoingLuminex Corporation
Medical DeviceMay 5, 2021
Clark Laboratories Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product recall — FDA Z-1503-2021
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Class IIFDA: TerminatedClark Laboratories, Inc.
Medical DeviceMay 5, 2021
Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular recall — FDA Z-1518-2021
Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility…
Class IIFDA: TerminatedOmnia SRL
Medical DeviceMay 5, 2021
Baxter Healthcare Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the recall — FDA Z-1487-2021
Potentially defective component in the AC power adapter which may fail over time.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceMay 5, 2021
DJ Orthopedics de Mexico S.A. de C.V DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15 recall — FDA Z-1512-2021
failed rivet at the chafe tab of arm sling.
Class IIFDA: TerminatedDJ Orthopedics de Mexico S.A. de C.V.
Medical DeviceMay 5, 2021
Medela AG Medical Technology Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing recall — FDA Z-1502-2021
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
Class IIFDA: TerminatedMedela AG Medical Technology
Medical DeviceMay 5, 2021
DJ Orthopedics de Mexico S.A. de C.V DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx recall — FDA Z-1511-2021
failed rivet at the chafe tab of arm sling.
Class IIFDA: TerminatedDJ Orthopedics de Mexico S.A. de C.V.
Medical DeviceMay 5, 2021
Smiths Medical ASD Palm Cups - Product Usage: intended to be used to percuss the chest wall recall — FDA Z-1515-2021
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceMay 5, 2021
Datascope Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic recall — FDA Z-1506-2021
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information…
Class IIIFDA: OngoingDatascope Corp.
Medical DeviceMay 5, 2021
Philips Xper Flex Cardio recall — FDA Z-1517-2021
Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 5, 2021
Smith & Nephew CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for recall — FDA Z-1510-2021
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceMay 5, 2021
Nextremity Solutions InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R recall — FDA Z-1501-2021
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of…
Class IIFDA: TerminatedNextremity Solutions
Medical DeviceMay 5, 2021
B. Braun Medical Filtered Triple-Leg Extension Set - Intravascular administration set recall — FDA Z-1509-2021
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceMay 5, 2021
DJ Orthopedics de Mexico S.A. de C.V DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx recall — FDA Z-1514-2021
failed rivet at the chafe tab of arm sling.
Class IIFDA: TerminatedDJ Orthopedics de Mexico S.A. de C.V.
Medical DeviceMay 5, 2021
Coltene Whaledent Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted recall — FDA Z-1494-2021
The incorrect dental pins were packaged and subsequently distributed.
Class IIFDA: OngoingColtene Whaledent Inc.
Medical DeviceMay 5, 2021
Smiths Medical ASD ACE MDI Spacer with Small Mask - Product Usage: designed to assist with recall — FDA Z-1516-2021
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceMay 5, 2021
Boston Scientific EXALT Controller - Product Usage: intended for use with a Boston recall — FDA Z-1492-2021
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Class IIIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMay 5, 2021
Boston Scientific Colpassist Vaginal Positioning Device - Product Usage: intended for use in recall — FDA Z-1490-2021
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMay 5, 2021
Datascope Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic recall — FDA Z-1507-2021
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information…
Class IIIFDA: OngoingDatascope Corp.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026111 records · 4 categoriesSeptember 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories