Medical DeviceAug 25, 2021
Delta Med SpA DELTAVEN Y DNL Safety I.V recall — FDA Z-2296-2021
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Class IIFDA: OngoingDelta Med SpA
August 2021 recalls — page 2
These records include useful source details for the selected month.
Medical DeviceAug 25, 2021
Delta Med SpA NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) recall — FDA Z-2301-2021
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Class IIFDA: OngoingDelta Med SpA
Medical DeviceAug 25, 2021
Cardinal Health 200 Argyle UVC Insertion Tray containing Safety Scalpel N11 recall — FDA Z-2244-2021
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the…
Class IFDA: TerminatedCardinal Health 200, LLC
Medical DeviceAug 25, 2021
Teleflex Medical Europe RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low recall — FDA Z-2322-2021
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Class IIFDA: TerminatedTeleflex Medical Europe Ltd
Medical DeviceAug 25, 2021
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 recall — FDA Z-2310-2021
The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.
Class IIFDA: OngoingOPTI Medical Systems, Inc.
Medical DeviceAug 25, 2021
Epimed International NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile recall — FDA Z-2313-2021
Potential for stylet to protrude from the distal end of the catheter
Class IIFDA: CompletedEpimed International
Medical DeviceAug 25, 2021
Teleflex Medical Europe RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal recall — FDA Z-2319-2021
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Class IIFDA: TerminatedTeleflex Medical Europe Ltd
Medical DeviceAug 25, 2021
Philips 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT recall — FDA Z-2314-2021
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceAug 25, 2021
Philips 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system recall — FDA Z-2316-2021
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceAug 25, 2021
Philips 728332 IQon Spectral CT-Computed Tomography X-ray system recall — FDA Z-2317-2021
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceAug 25, 2021
Philips 728333 Spectral CT 7500 -Computed Tomography X-ray system recall — FDA Z-2318-2021
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceAug 25, 2021
W L Gore & Associates Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter recall — FDA Z-2292-2021
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceAug 25, 2021
Boston Scientific TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) recall — FDA Z-2327-2021
Potential for leaks and loosening at the patient catheter connection
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceAug 25, 2021
Philips Respironics Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B recall — FDA Z-2288-2021
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second…
Class IIFDA: OngoingPhilips Respironics, Inc.
Medical DeviceAug 25, 2021
Philips Respironics Trilogy Evo Universal, Product number DS2000X11B recall — FDA Z-2290-2021
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second…
Class IIFDA: OngoingPhilips Respironics, Inc.
Medical DeviceAug 25, 2021
Ortho8 CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis recall — FDA Z-2324-2021
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Class IIFDA: OngoingOrtho8, Inc.
FoodAug 25, 2021
Able Groupe HiPP Dutch Stage 1 Combiotic Infant Milk Formula recall — FDA F-0909-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not…
Class IFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula recall — FDA F-0915-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Kendamil Organic Stage 1 First Infant Milk Formula recall — FDA F-0926-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe HiPP UK Stage 1 Combiotic First Infant Milk Formula recall — FDA F-0924-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not…
Class IFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Chicken of the Sea Genova Meal Kit recall — FDA F-0876-2021
Promotional Genova Meal Kits included products prepared in home kitchen that did not meet quality standards.
Class IIFDA: TerminatedChicken of the Sea; Thai Union
FoodAug 25, 2021
Able Groupe HiPP AR Germany Anti-Reflux Milk Formula recall — FDA F-0908-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Mane BBQ Seasoning Packaged in 50lb poly bag/cardboard box combo recall — FDA F-0874-2021
Ingredient used in manufacturing tested positive for Salmonella
Class IFDA: TerminatedMane Inc.
FoodAug 25, 2021
Able Groupe Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk recall — FDA F-0922-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
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.