Safety Recalls

15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 15,001–15,050 of 15,379

• Food Recall · November 8, 2023

  THE WIEDEMANN COMPANY LLC

  Tapee Tea packaged in paper packets - 5 packets per bag

  Samples confirm presence of dexamethasone and piroxicam

  Class I

• Medical Device Recall · November 8, 2023

  Getinge Usa Sales Inc

  Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211

  A potential for a light system to fall in the operating room.

  Class II

• Medical Device Recall · November 8, 2023

  Getinge Usa Sales Inc

  Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS M

  A potential for a light system to fall in the operating room.

  Class II

• Medical Device Recall · November 8, 2023

  Getinge Usa Sales Inc

  Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C,

  A potential for a light system to fall in the operating room.

  Class II

• Medical Device Recall · November 8, 2023

  Getinge Usa Sales Inc

  Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII7

  A potential for a light system to fall in the operating room.

  Class II

• Medical Device Recall · November 8, 2023

  Getinge Usa Sales Inc

  Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C,

  A potential for a light system to fall in the operating room.

  Class II

• Medical Device Recall · November 8, 2023

  Getinge Usa Sales Inc

  Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

  A potential for a light system to fall in the operating room.

  Class II

• Medical Device Recall · November 8, 2023

  Getinge Usa Sales Inc

  Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD56750

  A potential for a light system to fall in the operating room.

  Class II

• Medical Device Recall · November 8, 2023

  Getinge Usa Sales Inc

  Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD56

  A potential for a light system to fall in the operating room.

  Class II

• Vehicle Recall · November 7, 2023

  Prevost Car (US) Inc.

  2024 PREVOST H3-45

  An inoperative front turn signal may not notify other drivers of a turning vehicle, while inoperative hazard warning lights reduce the vehicle visibility to other drivers, both increasing the risk of a crash.

  Unclassified

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008,

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Medical Device Recall · November 7, 2023

  Medtronic Xomed, Inc.

  NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8

  Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

  Class II

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Vehicle Recall · November 7, 2023

  Gulf States Toyota, Inc.

  2023 TOYOTA RAV4

  A damaged or improperly installed valve stem may allow air to leak and/or the tires to be underinflated, increasing the risk of tire failure and a crash.

  Unclassified

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the b

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.

  Class II

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Medical Device Recall · November 7, 2023

  Abiomed, Inc.

  Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025

  Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

  Class II

• Medical Device Recall · November 6, 2023

  Merit Medical Systems, Inc.

  Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2

  The sterility of microcatheter and infusion system devices cannot be guaranteed.

  Class II

• Medical Device Recall · November 6, 2023

  Merit Medical Systems, Inc.

  Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY

  The sterility of microcatheter and infusion system devices cannot be guaranteed.

  Class II

• Medical Device Recall · November 6, 2023

  Sarnova HC, Llc

  Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.

  It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

  Class II

• Medical Device Recall · November 6, 2023

  Randox Laboratories Ltd.

  SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxopla

  A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

  Class III

• Medical Device Recall · November 6, 2023

  Olympus Corporation of the Americas

  Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, a

  Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

  Class II

• Medical Device Recall · November 6, 2023

  Sarnova HC, Llc

  Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.

  It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

  Class II

• Medical Device Recall · November 6, 2023

  Merit Medical Systems, Inc.

  Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY

  The sterility of microcatheter and infusion system devices cannot be guaranteed.

  Class II

• Vehicle Recall · November 5, 2023

  General Motors, LLC

  2023 CHEVROLET EQUINOX, 2023 GMC TERRAIN

  The inability to install a child seat with the LATCH anchorage bars could result in an unsecured child seat, increasing the risk of injury in a crash.

  Unclassified

• Vehicle Recall · November 5, 2023

  Chrysler (FCA US, LLC)

  2023 JEEP GRAND CHEROKEE

  Without a label that shows the proper restraint usage guidelines, the occupants may have an increased risk of injury in the event of a crash.

  Unclassified

• Medical Device Recall · November 2, 2023

  Fujifilm Irvine Scientific, Inc.

  Sperm separation media are used to separate motile sperm from other constituents of semen.

  The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).

  Class II

• Medical Device Recall · November 1, 2023

  Atrium Medical Corporation

  Atrium Oasis Drain Single W / AC, Part No. 3600-100

  A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.

  Class II

• Medical Device Recall · November 1, 2023

  Turncare, Inc

  Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

  A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

  Class II

• Medical Device Recall · October 30, 2023

  KENT IMAGING, INC.

  Snapshot NIR, REF: KD204

  Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.

  Class II

• Medical Device Recall · October 30, 2023

  Folsom Metal Products, Inc.

  DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lig

  Units were not intended for commercial distribution and inadvertently distributed.

  Class II

• Medical Device Recall · October 30, 2023

  Folsom Metal Products, Inc.

  Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Sma

  Units were not intended for commercial distribution and inadvertently distributed.

  Class II

• Food Recall · October 25, 2023

  Wakefern Foods Corp.

  Bowl & Basket Zero Calorie with Sucralose Sweetener 100 count, UPC 0-41190-06855-5, 12 retail cartons per wholesale case

  Undeclared aspartame lack of phenylalanine warning

  Class III

• Medical Device Recall · October 25, 2023

  PHASE SCIENTIFIC INTERNATIONAL LIMITED

  INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

  COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.

  Class II

• Medical Device Recall · October 25, 2023

  Becton, Dickinson and Company, BD Biosciences

  CD11b APC: ASR, REF: 340936, and CE, REF: 333143

  In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

  Class II

• Medical Device Recall · October 24, 2023

  GRAPHENANO DENTAL SL

  GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090;

  Machining error on cams renders the device unusable.

  Class II

• Medical Device Recall · October 24, 2023

  Fresenius Medical Care Holdings, Inc.

  Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

  Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

  Class III

• Medical Device Recall · October 19, 2023

  Abbott Laboratories

  Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest p

  The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

  Class II

• Medical Device Recall · October 19, 2023

  Abbott Laboratories

  ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing p

  The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

  Class II

• Medical Device Recall · October 19, 2023

  Abbott Laboratories

  Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest

  The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

  Class II

• Medical Device Recall · October 16, 2023

  Zimmer Biomet Spine Inc.

  Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

  Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.

  Class II

• Medical Device Recall · October 16, 2023

  MEDLINE INDUSTRIES, LP - Northfield

  (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.

  The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

  Class I

• Medical Device Recall · October 16, 2023

  MEDLINE INDUSTRIES, LP - Northfield

  Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile;

  The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

  Class I

• Medical Device Recall · October 16, 2023

  MEDLINE INDUSTRIES, LP - Northfield

  (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For

  The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

  Class I

• Medical Device Recall · October 11, 2023

  Mc3 Inc

  NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145;

  May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer

  Class II