Medical DeviceJul 21, 2021
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product recall — FDA Z-2069-2021
Marketed without a 510K
Class IIFDA: OngoingArrow International Inc.
July 2021 recalls — page 6
These records include useful source details for the selected month.
Medical DeviceJul 21, 2021
GE Healthcare SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With recall — FDA Z-2057-2021
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJul 21, 2021
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 recall — FDA Z-2068-2021
Marketed without a 510K
Class IIFDA: OngoingArrow International Inc.
Medical DeviceJul 21, 2021
Baxter Healthcare EASYGRIP FLO-41 US recall — FDA Z-2051-2021
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJul 21, 2021
Axonics Modulation Technologies BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing recall — FDA Z-2077-2021
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Class IIFDA: TerminatedAxonics Modulation Technologies, Inc.
Medical DeviceJul 21, 2021
GE Healthcare SIGNA Artist, Nuclear Magnetic Resonance Imaging System recall — FDA Z-2061-2021
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJul 21, 2021
Tornier Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx recall — FDA Z-2025-2021
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Class IIFDA: TerminatedTornier, Inc.
Medical DeviceJul 21, 2021
Heartware recall — FDA Z-2072-2021
The pump has an impeller with a shroud height that did not meet the lower control limit.
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceJul 21, 2021
GE Healthcare SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner recall — FDA Z-2052-2021
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJul 21, 2021
IMPLANTCAST GMBH EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit recall — FDA Z-2050-2021
A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning…
Class IIFDA: TerminatedIMPLANTCAST GMBH
Medical DeviceJul 21, 2021
Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous recall — FDA Z-1956-2021
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas…
Class IFDA: OngoingPhilips Respironics, Inc.
FoodJul 21, 2021
Bea Lydeckers Naturals Living Free Heart/Blood Vessel Dietary Supplement, 100 or 500 recall — FDA F-0777-2021
Label declares lecithin but does not declare soy lecithin.
Class IIFDA: TerminatedBea Lydeckers Naturals Inc.
FoodJul 21, 2021
Bazzini Trader Joes Dark Chocolate Almond Butter Cup, 1.4 oz recall — FDA F-0772-2021
Potential undeclared peanut allergen.
Class IIFDA: TerminatedBazzini LLC
FoodJul 21, 2021
Bea Lydeckers Naturals Living Free Lung & Joint Congestion Herbal Dietary Supplement recall — FDA F-0779-2021
Label declares lecithin but does not declare soy lecithin.
Class IIFDA: TerminatedBea Lydeckers Naturals Inc.
FoodJul 21, 2021
Bea Lydeckers Naturals Living Free "Adult Extra" multi-vitamin, 100 or 500 capsules recall — FDA F-0776-2021
Label declares lecithin but does not declare soy lecithin.
Class IIFDA: TerminatedBea Lydeckers Naturals Inc.
FoodJul 21, 2021
Bea Lydeckers Naturals Living Free Nerve & Muscle Herbal Dietary Supplement, 100 and recall — FDA F-0780-2021
Label declares lecithin but does not declare soy lecithin.
Class IIFDA: TerminatedBea Lydeckers Naturals Inc.
FoodJul 21, 2021
Bea Lydeckers Naturals Living Free Immune Dietary Supplement, 100 and 500 capsules recall — FDA F-0778-2021
Label declares lecithin but does not declare soy lecithin.
Class IIFDA: TerminatedBea Lydeckers Naturals Inc.
FoodJul 21, 2021
Bea Lydeckers Naturals Living Free Nerve & Muscle Plus Cetyl-Myristoleate Herbal and recall — FDA F-0781-2021
Label declares lecithin but does not declare soy lecithin.
Class IIFDA: TerminatedBea Lydeckers Naturals Inc.
DrugJul 21, 2021
Yamtun7 Poseidon Platinum 3500 capsule, 1-count per blister card recall — FDA D-0654-2021
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established…
Class IFDA: TerminatedYamtun7
DrugJul 21, 2021
Sanit Technologies, LLC dba Durisan Durisan Antimicrobial Solutions (benzalkonium chloride) recall — FDA D-0656-2021
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
Class IFDA: TerminatedSanit Technologies, LLC dba Durisan
DrugJul 21, 2021
Sanit Technologies, LLC dba Durisan Durisan Antimicrobial Solutions (benzalkonium chloride) recall — FDA D-0659-2021
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class IIFDA: TerminatedSanit Technologies, LLC dba Durisan
DrugJul 21, 2021
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg recall — FDA D-0652-2021
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugJul 21, 2021
Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer recall — FDA D-0694-2021
Hand sanitizer packaged in bottles that resemble beverage containers.
Class IFDA: TerminatedPrairie Wolf Spirits
DrugJul 21, 2021
Ardil Comercial S.R.L Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles recall — FDA D-0691-2021
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class IFDA: OngoingArdil Comercial S.R.L.
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.