The Recall Desk

Archive

October 2020 recalls

622 recalls were announced in October 2020.

What the numbers show

Critical
84
Severe
123
High
313
Moderate
83
Low
19

Of the 622 recalls this month scored against our rubric, 14% are Critical, 20% are Severe.

1–100 of 622

  • SevereNHTSA·20V672000·2020-10-30

    Mercedes-Benz Recalls 2019 GLA 250 for Loose Engine Fusebox

    Mercedes-Benz is recalling 2019 GLA 250 vehicles because a loose engine compartment fusebox may damage fuses and disrupt critical safety systems, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V673000·2020-10-30

    2020 Mercedes-Benz AMG E53 front passenger seat adjustment recall

    Mercedes-Benz is recalling certain 2019-2021 vehicles because the front passenger seat may be missing a mechanical adjustment limit stop. The seat could move outside the safe range relative to the airbag, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 350, E63 AMG, AMG E53, E 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V671000·2020-10-30

    Mercedes-Benz Recalls GLE Models Due to Middle Seat Belt Buckle Defect

    Mercedes-Benz is recalling certain 2020-2021 GLE models because the middle seat belt buckle may fall into a gap, rendering it inoperable and leaving occupants unrestrained.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450, AMG GLE53, GLE 580
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21017·2020-10-29

    Mueller Austria Onion Chopper Pro Recalled for Laceration Hazard

    Mueller Austria is recalling Onion Chopper Pro units because a locking tab can detach, allowing hands to slide into the blades. The company reported 137 laceration injuries.

    Product
    Mueller Austria Onion Chopper Pro
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V668000·2020-10-29

    GM Recalls Vehicles for Missing Start-Stop Accumulator Bolts

    General Motors is recalling specific 2018-2020 vehicles because missing bolts on the start/stop accumulator may cause transmission leaks, loss of propulsion, or fire.

    Product
    GMC — GMC, CHEVROLET, CADILLAC TERRAIN, CRUZE, EQUINOX, XT4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V669000·2020-10-29

    Triple E RV Recalls Motorhomes Due to Propane Leak Risk

    Triple E RV is recalling 2019-2021 motorhomes because an incorrect brass connector on the water heater may cause a propane leak, increasing fire risk.

    Product
    TRIPLE E RV — TRIPLE E RV, SERENITY, TRIPLE E WONDER, S24CB, UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V666000·2020-10-29

    BMW Recalls M2 and M4 Coupes for Fuel Injector Vibration Risk

    BMW is recalling 2020-2021 M2 and 2020 M4 Coupes because missing fuel injector components may cause vibration, leading to fuel leaks and fire risk.

    Product
    BMW — BMW M2, M4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V667000·2020-10-29

    Jayco and Entegra motorhomes recalled for insufficient engine cover insulation

    Jayco, Inc. is recalling certain 2020-2021 motorhomes due to engine covers with insufficient heat insulation. This may cause excessive interior surface temperatures that increase the risk of injury to occupants.

    Product
    ENTEGRA — ENTEGRA, JAYCO VISION XL, EMBLEM, ALANTE, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0036-2021·2020-10-28

    High Quality Organics Recalls Organic White Wine Shallot Seasoning for Salmonella

    High Quality Organics is recalling Organic White Wine Shallot Seasoning because a customer test confirmed the presence of Salmonella in organic parsley.

    Product
    Vox Spice, Allegro Coffee Company Organic White Wine Shallot Seasoning; Food Service 90 oz.PET jar; 4 jars per case UPC: 014321561362; Blend Formula Number 2431A9KV1, 50 lb. box.
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0039-2021·2020-10-28

    Sauer Brands Organic Parsley Recalled for Potential Salmonella Contamination

    Sauer Brands Inc is recalling The Spice Hunter Organic Parsley jars due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Organic Parsley 0.23 oz. Jar UPC 8105701659 Case UPC 40081057016594
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0062-2021·2020-10-28

    Sauer Brands Recalls The Spice Hunter Arrowroot Due to Salmonella Risk

    Sauer Brands Inc is recalling The Spice Hunter Arrowroot jars due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Arrowroot 2.1 oz. Jar UPC 8105701050 Case UPC 40081057010509
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0038-2021·2020-10-28

    Red Monkey Foods Recalls Herbes de Provence Due to Salmonella Risk

    Red Monkey Foods Inc is recalling specific packages of Herbes de Provence because an ingredient tested positive for Salmonella.

    Product
    Herbes de Provence packaged in the following ways: 1) World Market, Organic Herbs De Provence, Net Wt. 0.6 OZ (17 g), Distributed by Cost Plus, Inc., Alameda, CA UPC 2533 3107; 2) Organics, Herbs De Provence, Net Wt. 0.65 OZ (18 g), Distributed by Lucerne Foods, Inc., Pleasan
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0063-2021·2020-10-28

    Sauer Brands Recalls Cayenne Red Pepper Jars Due to Salmonella Risk

    Sauer Brands Inc is recalling 45,498 bottles of The Spice Hunter Cayenne Red Pepper due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Cayenne Red Pepper 1.8 oz. Jar UPC 8105701170 Case UPC 40081057011704
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0060-2021·2020-10-28

    Sauer Brands Recalls Fennel Seeds Due to Potential Salmonella Contamination

    Sauer Brands Inc is recalling The Spice Hunter Fennel Seeds due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Fennel Seeds 1.3 oz. Jar UPC 8105741363 Case UPC 40081057413630
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0035-2021·2020-10-28

    Acella Recalls NP Thyroid 15 Tablets Due to Subpotent Levothyroxine

    Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because FDA analysis found the levothyroxine content was less than the labeled claim.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0041-2021·2020-10-28

    Sauer Brands Recalls Madagascar Cloves Due to Potential Salmonella Contamination

    Sauer Brands Inc is recalling 648 jars of The Spice Hunter Madagascar Cloves due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Madagascar Cloves 1.9 oz. Jar UPC 8105701260 Case UPC 40081057012602
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0045-2021·2020-10-28

    Sauer Brands Recalls The Spice Hunter Seafood Grill & Broil Seasoning

    Sauer Brands Inc is recalling The Spice Hunter Seafood Grill & Broil seasoning due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Seafood Grill & Broil 1.3 oz. Jar UPC 8105701935 Case UPC 40081057019359
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0037-2021·2020-10-28

    Red Monkey Foods Recalls Dried Parsley Due to Salmonella Contamination

    Red Monkey Foods Inc. is recalling 1,130 cases of dried parsley products because the ingredient tested positive for Salmonella. The products were distributed to retail stores nationwide.

    Product
    Dried Parsley packaged in the following ways: 1) World Market, Organic Parsley NET WT. 0.3 OZ (8.5 g), Distributed by Cost Plus, Inc., Alameda, CA UPC 2533 3251; 2) Organics, Organic Parsley, NET WT. 0.3 OZ (8.5 g), Distributed by Lucerne Foods, Inc., Pleasanton, CA UPC 0 798
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0035-2021·2020-10-28

    High Quality Organics Organic Meatball Seasoning Recalled for Salmonella

    High Quality Organics is recalling 450 lbs of Organic Meatball Seasoning because a customer test confirmed the presence of Salmonella.

    Product
    High Quality Organics Organic Meatball Seasoning 50 lbs. Formula number: 2509A9KV6 Item # 200479
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0051-2021·2020-10-28

    Sauer Brands Recalls The Spice Hunter Paprika Due to Salmonella Risk

    Sauer Brands Inc is recalling The Spice Hunter Paprika jars due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Paprika 1.4 oz. Jar UPC 8105701653 Case UPC 40081057016532
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0053-2021·2020-10-28

    Sauer Brands Recalls Chinese Ginger Jars Due to Salmonella Risk

    Sauer Brands Inc is recalling 45,498 bottles of The Spice Hunter Chinese Ginger due to potential Salmonella contamination. The product was sold nationwide and online.

    Product
    The Spice Hunter Chinese Ginger 1.6 oz. Jar UPC 8105701420 Case UPC 40081057014200
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0058-2021·2020-10-28

    Sauer Brands Recalls Italian Seasoning Jars Due to Salmonella Risk

    Sauer Brands Inc is recalling 5,076 jars of The Spice Hunter Italian Seasoning due to potential Salmonella contamination. The product was sold nationwide and online.

    Product
    The Spice Hunter Italian Seasoning 0.6 oz. Jar UPC 8105701450 Case UPC 40081057014507
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0112-2021·2020-10-28

    Homestead Creamery Recalls Chocolate Ice Cream Due to Undeclared Pecans

    Homestead Creamery is recalling 203 quarts of chocolate ice cream because it contains undeclared pecans, posing a risk to people with tree nut allergies.

    Product
    Chocolate Ice Cream, 1 quart, UPC:87525200107. Packaged in paper quart container.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0047-2021·2020-10-28

    Sauer Brands Recalls Garlic Products Due to Potential Salmonella Contamination

    Sauer Brands Inc is recalling specific lots of The Spice Hunter California Garlic and Roasted Garlic due to potential Salmonella contamination.

    Product
    The Spice Hunter California Garlic 2.7 oz. Jar UPC 8105701400 Case UPC 40081057014002, Roasted Garlic 2.2 oz. Jar UPC 8105701402 Case UPC 40081057014026
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0179-2021·2020-10-28

    Stryker S2 Mini Foot Pedal Recalled Due to Magnet Defect

    Bien-Air Surgery is recalling Stryker S2 Mini Foot Pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot ped
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0059-2021·2020-10-28

    Sauer Brands Recalls The Spice Hunter Cilantro Jars Due to Salmonella Risk

    Sauer Brands Inc is recalling The Spice Hunter Cilantro jars due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Cilantro 0.3 oz. Jar UPC 8105701236 Case UPC 40081057012367
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0088-2021·2020-10-28

    Medtronic Recalls Rashkind Balloon Septostomy Catheters Due to Field Failures

    Medtronic Vascular is recalling 711 units of Rashkind Balloon Septostomy Catheters due to subsequent field failures and failed quality testing.

    Product
    Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a tre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0034-2021·2020-10-28

    High Quality Organics Recalls Organic Parsley Due to Salmonella

    High Quality Organics is recalling organic parsley after a customer test confirmed the presence of Salmonella.

    Product
    High Quality Organics Organic Parsley, Medium, Organic Parsley Fines 50 lbs. 25 lbs. 20 lbs. 0.25 lbs.
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·20V663000·2020-10-28

    Daimler Recalls 2015-2020 Sprinter Vans for Steering Hose Defect

    Daimler Vans USA is recalling 2015-2020 Mercedes-Benz and Freightliner Sprinter vans because hydraulic power steering hoses may detach, causing fluid leaks and loss of steering assist.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 1500, SPRINTER 2500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0128-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the power cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0203-2021·2020-10-28

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30)50(10)4557524. The Intravascular Administration Set is a single use, sterile, non-pyrogenic dev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0230-2021·2020-10-28

    ICU Medical Recalls 114-inch Burette Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 114-inch burette sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709091747(17)241201(30)25(10)4476428;(01)10887709091747(17)250101(30)25(10)47128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0258-2021·2020-10-28

    ICU Medical Recalls Burette Sets Due to Potential Manufacturing Defect

    ICU Medical is recalling specific lots of 112-inch burette sets because a manufacturing defect may prevent a proper seal with the NanoClave spike.

    Product
    112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709079127(17)250201(30)25(10)4727501. The Intravascular Administration Set is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0255-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect on the NanoClave may prevent a proper seal with the spike.

    Product
    148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0118-2021·2020-10-28

    Smith & Nephew Recalls Genesis Knee Implants Due to Design Defect

    Smith & Nephew is recalling 47 Genesis knee implants because the anterior locking detail does not meet design specifications.

    Product
    Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0189-2021·2020-10-28

    ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 9-inch Smallbore Bifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709052953(17)241201(30)50(10)4536611;(01)10887709052953(17)250101(30)50(10)4557492 The In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0130-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the Power Gradient & RF Cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0122-2021·2020-10-28

    Baxter SIGMA Spectrum Infusion Pump Recall for Safety Communication Update

    Baxter Healthcare is recalling 152,539 SIGMA Spectrum Infusion Pumps to update the Instructions for Use (IFU) regarding cleaning practices.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0127-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Potential Electrical Arc Flash

    GE Healthcare is recalling 30 MRI systems due to a potential electrical arc flash hazard within the Power Gradient & RF cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0129-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the power cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0131-2021·2020-10-28

    GE Healthcare Recalls PET/MR Imagers Due to Electrical Arc Flash Risk

    GE Healthcare is recalling specific PET/MR imager models due to a potential electrical arc flash hazard within the Power Gradient & RF Cabinet.

    Product
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0176-2021·2020-10-28

    Bien-Air Surgery Foot Pedal Recalled Due to Magnet Detachment Risk

    Bien-Air Surgery is recalling 1,120 foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0222-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0119-2021·2020-10-28

    Olympus Choledoscope Recalled for Lack of Clearance and Breakage

    Olympus is recalling CHF-CB30S choledoscopes because they lack FDA clearance and have experienced breakage and metal protrusion during use.

    Product
    Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0114-2021·2020-10-28

    Stryker Trevo XP ProVue Retriever Recalled for Core Wire Fracture

    Stryker Neurovascular is recalling Trevo XP ProVue Retriever devices due to increased fracture complaints of the core wire, which can cause the stent retriever to separate and remain in the patient's vasculature.

    Product
    Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M00
    Category
    Medical Device
    Distribution
    48 states
  • SevereFDA (Devices)·Z-0180-2021·2020-10-28

    Entellus Medical Shaver System Foot Pedal Recalled for Magnet Defect

    Bien-Air Surgery Sa is recalling Entellus Medical Shaver System foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0177-2021·2020-10-28

    Bien-Air Surgery Multifunction Pedal Recalled Due to Magnet Failure Risk

    Bien-Air Surgery is recalling 1,120 OsseoDuo multifunction foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets due to a manufacturing defect that may prevent a proper seal.

    Product
    11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; (01)10840619059801(17)241201(30)50(10)4514500; (01)10840619059801(17)250201(30)50(10)4727354. Administration sets and their acc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)10887709085227(17)250101(30)50(10)4589920; (01)10887709085227(17)250101(30)50(10)4572950. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2021·2020-10-28

    Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors for Seal Issues

    Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2021·2020-10-28

    Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors

    Smith & Nephew is recalling Ultra Fast-Fix AB Assembly suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0055-2021·2020-10-28

    Sauer Brands Recalls Everything Bagel Crunch for Potential Salmonella

    Sauer Brands Inc is recalling The Spice Hunter Everything Bagel Crunch due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Everything Bagel Crunch 2.3 oz. Jar UPC 8105701351 Case UPC 40081057013517
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Packaging Seal Issues

    Smith & Nephew is recalling TWINFIX 6.5mm suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2021·2020-10-28

    ICU Medical Recalls NanoClave Sets Due to Potential Manufacturing Defect

    ICU Medical is recalling specific lots of NanoClave sets because a manufacturing defect may prevent a proper seal, potentially affecting intravascular administration.

    Product
    120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040141(17)250101(30)25(10)4573652. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0061-2021·2020-10-28

    Sauer Brands Recalls Dill Weed Jars Due to Salmonella Risk

    Sauer Brands Inc is recalling The Spice Hunter Dill Weed jars due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Dill Weed 0.5 oz. Jar UPC 8105701348 Case UPC 40081057013487
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0248-2021·2020-10-28

    ICU Medical Recalls ChemoClave Sets Due to Potential Seal Defect

    ICU Medical is recalling ChemoClave needle-free transfer sets because a manufacturing defect may prevent a proper seal, potentially allowing contaminants to enter the system.

    Product
    6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2021·2020-10-28

    Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors

    Smith & Nephew is recalling Ultra Fast-Fix AB Assembly curved absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2021·2020-10-28

    ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore bifuse extension sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.

    Product
    5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101(30)50(10)4603262. The Intravascular Administration Set is a single use, sterile, non-pyrogenic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2021·2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265; (01)10887709087526(17)250201(30)50(10)4724859; (01)10887709087526(17)250201(30)50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2021·2020-10-28

    ICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect

    ICU Medical is recalling specific lots of NanoClave Connectors because a manufacturing defect may prevent a proper seal with the spike.

    Product
    NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravasc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460; (01)10887709095298(17)250101(30)25(10)4589956; (01)10887709095298(17)250201(30)25(10)4711185.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2021·2020-10-28

    Smith & Nephew Recalls Microraptor RegenSorb Suture Anchors for Seal Issues

    Smith & Nephew is recalling Microraptor RegenSorb Suture Anchors because improper or incomplete pouch seals may breach the sterile barrier.

    Product
    MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2021·2020-10-28

    BD Nexiva Closed IV Catheter System Recalled for Dull Needles

    Becton Dickinson is recalling 12,020 units of BD Nexiva Closed IV Catheter Systems due to dull needles that may delay medical treatment.

    Product
    BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0266-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent the spike from sealing properly.

    Product
    8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)250201(30)50(10)4717491. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0253-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave Intravascular Administration Sets due to a manufacturing defect that may prevent a proper seal.

    Product
    60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0263-2021·2020-10-28

    ICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect

    ICU Medical is recalling specific lots of NanoClave Connectors due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.

    Product
    NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111; (01)10840619060906(17)2412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709099859(17)241201(30)50(10)4536666. Administration sets and their accessories are single use, pre-sterilized devices that provi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2021·2020-10-28

    Siemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results

    Siemens Healthcare Diagnostics is recalling Alkaline Phosphatase (ALPI) Flex reagent cartridges due to low outlier test results. The recall covers 5,970 US units and 1,446 international units.

    Product
    Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;(01)10887709074696(17)250201(30)25(10)4719610. . The Intravascular Administration Set is a singl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2021·2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10840619066014(17)250201(30)50(10)4718521;(01)10840619066014(17)250201(30)50(10)4735100. Administration sets and their acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2021·2020-10-28

    Bien-Air Surgery OSSEOSTAP Footcontrol Recalled for Magnet Defect

    Bien-Air Surgery is recalling OSSEOSTAP foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2021·2020-10-28

    ICU Medical Recalls NanoClave Stopcock Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave stopcock sets due to a manufacturing defect that may prevent a proper seal.

    Product
    Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10)4549131. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device whi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0268-2021·2020-10-28

    ICU Medical Recalls Smallbore Quadfuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of Smallbore Quadfuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case. UDI:(01)10840619076174(17)250201(30)50(10)4735112; (01)10840619076174(17)241201(30)50(10)4493240. Administration sets and their accessories are single use, pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21015·2020-10-28

    Ron Jon Surf Shop Sippy Cup Recalled for Lead and Phthalates

    Porter World Trade is recalling Ron Jon Surf Shop Sippy Cups because the plastic characters contain lead and phthalates exceeding federal bans. No injuries have been reported.

    Product
    Ron Jon Surf Shop Sippy Cup
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of NanoClave administration sets due to a potential manufacturing defect on the internal surface that may inhibit a proper seal.

    Product
    165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)241201(30)50(10)4553703. Administration sets and their accessories are single use, pre-sterilized devices that provide access for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the stopcock from sealing properly.

    Product
    22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10887709051967(17)250201(30)50(10)4727498. The Intravascular Administration Set is a single use, st
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 5.0mm AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0136-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 5.0mm suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2021·2020-10-28

    Maquet Yuno Mobile Operating Table Recalled for Electric Shock Risk

    Maquet is recalling Yuno Mobile Operating Tables because a plastic socket may pull out, exposing electronic parts and creating an electric shock hazard.

    Product
    Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2021·2020-10-28

    ICU Medical Recalls APPX NanoClave Manifold Sets Due to Seal Defect

    ICU Medical is recalling APPX 0.75 ml, 6-Port NanoClave Manifold sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(10)4549203; (01)10887709070551(17)250101(30)50(10)4558619; (01)10887709070551(17)250101(30)50(10)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 6-inch Intravascular Administration Sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)10887709079877(17)250101(30)50(10)4559022. The Intravascular Administration Set is a single use, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709070902(17)250201(30)50(10)4724881. The Intravascular Administration Set is a single use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0050-2021·2020-10-28

    Sauer Brands Recalls Mexican Seasoning for Potential Salmonella Contamination

    Sauer Brands Inc is recalling The Spice Hunter Mexican Seasoning due to potential Salmonella contamination. The product was distributed nationwide and online.

    Product
    The Spice Hunter Mexican Seasoning 1.4 oz. Jar UPC 8105701541 Case UPC 40081057015412
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0027-2021·2020-10-28

    Shirakiku Black Fungus Recalled Due to Salmonella Contamination

    Wismettac Asian Foods is recalling Shirakiku brand Black Fungus because testing found Salmonella. Consumers should discard the product.

    Product
    Shirakiku brand Black Fungus (Kikurage); 5 lb. bag, 6 x 5 lb. bags per case Item # 60403; UPC 0 74410 60403 5 Ingredients: Back Fungus, Contains: Sulfites Product of China Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA, 90670
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-0026-2021·2020-10-28

    Marketside Cranberry Walnut Salad Recalled for Undeclared Wheat and Walnuts

    Taylor Farms is recalling Marketside Cranberry Walnut Salad because the ingredient statement fails to declare wheat and walnuts.

    Product
    Marketside brand Cranberry Walnut Salad in 4.5 oz. plastic bowl with poly film lidding (6 bowls per case). UPC: 583243601
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0277-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709075501(17)250101(30)50(10)4558474. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50(10)4603496. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device
    Category
    Medical Device
    Distribution
    Distributed nationwide

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