The Recall Desk

Archive

August 2021 recalls

482 recalls were announced in August 2021.

What the numbers show

Critical
11
Severe
122
High
293
Moderate
54
Low
2

Of the 482 recalls this month scored against our rubric, 2% are Critical, 25% are Severe.

Which agencies issued them

101–200 of 482

  • HighFDA (Food)·F-0867-2021·2021-08-25

    Moonwalk 70% Dark Chocolate Bar Recalled for Undeclared Milk

    Cocanu LLC is recalling Moonwalk 70% dark chocolate bars because milk is not declared on the label, even though lactose is present. The product may pose a risk to consumers with milk allergies.

    Product
    Moonwalk 70% dark chocolate bar. It is packaged in white shiny paper with blue print. Net Weight: 1.2 oz / 35gr. No UPC. The label is read in parts: "***Moonwalk ***a 70% dark chocolate bar ***chocolate, cacao nibs and pop rocks ***Contents: cacao beans, cacao butter, cane sug
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2317-2021·2021-08-25

    IQon Spectral CT System Software Error Increases Contrast Volume

    Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.

    Product
    728332 IQon Spectral CT-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2021·2021-08-25

    CT X-ray System Software Miscalculates Contrast Volume with Pounds Unit Setting

    Philips 728333 Spectral CT 7500 systems with SynchRight software may incorrectly calculate and recommend increased contrast volume when patient weight is set to pounds. Affected system should be updated to prevent excess contrast dosing.

    Product
    728333 Spectral CT 7500 -Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2021·2021-08-25

    DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect

    Delta Med is recalling DELTAVEN Y IV Catheters in Florida and Minnesota due to potential sterilization defects. The devices may not be properly sterilized, posing infection risks to patients.

    Product
    DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2021·2021-08-25

    Surgical stapler mislabeled with incorrect device size

    Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.

    Product
    ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2021·2021-08-25

    CIRCUL8 LUXE DVT Prevention Device Marketed Without FDA Clearance

    The CIRCUL8 LUXE DVT Prevention Device is being recalled because it was marketed without FDA clearance. The device is intended to aid in the prevention of deep vein thrombosis.

    Product
    CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2021·2021-08-25

    I.V. Catheter Recall Due to Sterilization Failures

    Delta Med is recalling approximately 1,400 NEO DELTA SELFSAFE PUR 1 I.V. catheters (Lot 00A1160806) distributed in Florida and Minnesota due to sterilization process defects that may result in non-sterile devices.

    Product
    NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0927-2021·2021-08-25

    Kendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling

    Able Groupe Inc is recalling Kendamil Organic Stage 2 Follow on Milk Formula because required pre-market FDA notifications were not submitted and labeling does not comply with federal requirements.

    Product
    Kendamil Organic Stage 2 Follow on Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2306-2021·2021-08-25

    Philips EPIQ Ultrasound Systems Control Panel Arm Swivel Lock May Fail

    Philips EPIQ ultrasound system control panel arm swivel locks can fail, allowing the monitor to swivel freely during positioning or transport, potentially causing user or patient musculoskeletal injury.

    Product
    EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2021·2021-08-25

    Trilogy Evo Ventilator Software Defect May Cause Pressure Increase

    Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.

    Product
    Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2307-2021·2021-08-25

    Oxygen Sensors in Incubators May Display Inaccurate Readings

    CooperSurgical oxygen sensors in incubators may display inaccurate oxygen readings that do not trigger alarms when discrepancies occur. This could result in loss of embryos during storage.

    Product
    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standa
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2289-2021·2021-08-25

    Trilogy EV300 Ventilator Recalled for Software-Related Pressure Calibration Issues

    Philips Respironics is recalling the Trilogy EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.

    Product
    Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2021·2021-08-25

    TheraSphere Administration Set may leak or loosen at catheter connection

    Boston Scientific is recalling TheraSphere Administration Sets due to potential leaks and loosening at the patient catheter connection. Approximately 4,200 sets were distributed worldwide.

    Product
    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2021·2021-08-25

    Dual Balloon Angioplasty Catheter Recalled for Balloon Deflation Difficulty

    Ostial Corporation is recalling the FLASH Ostial System dual balloon angioplasty catheter due to a manufacturing issue that may prevent proper balloon deflation, potentially causing access site complications.

    Product
    FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2021·2021-08-25

    Soltive Laser Systems recalled for thermal burn injury risk during stone treatment

    Olympus is recalling Soltive laser systems used in urological surgery because exceeding recommended power settings can cause thermal burns to tissue during kidney stone treatment.

    Product
    Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterologica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2021·2021-08-25

    RUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response

    Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.

    Product
    RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2021·2021-08-25

    Evexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance

    Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.

    Product
    EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2021·2021-08-25

    Trilogy Evo Respiratory Device Recalled for Software Pressure Issues

    Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.

    Product
    Trilogy Evo Universal, Product number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0724-2021·2021-08-25

    Combipatch Transdermal System Recalled for Failed Stability Specifications

    Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.

    Product
    COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0726-2021·2021-08-25

    Gavilyte-C Oral Solution Recalled for Failed Stability Specification

    Novel Laboratories/Lupin Pharmaceuticals is recalling Gavilyte-C (polyethylene glycol-3350 and electrolytes with flavor pack) due to failed stability testing and out-of-specification osmolarity. The product is distributed nationwide.

    Product
    GAVILYTE - C — GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0751-2021·2021-08-25

    Econazole Nitrate Cream 1% recalled due to labeling mispack

    Teligent Pharma is recalling Econazole Nitrate Cream 1% in 85-gram bulk tubes due to incorrect labeling. The product was distributed nationwide.

    Product
    Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0729-2021·2021-08-25

    Acetaminophen 325 mg tablets recalled for discoloration and cGMP deviations

    Spirit Pharmaceuticals is recalling Acetaminophen 325 mg Regular Strength Pain Reliever tablets due to discoloration and current good manufacturing practice (cGMP) deviations. The recall affects one lot distributed nationwide.

    Product
    Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0876-2021·2021-08-25

    Chicken of the Sea Genova Meal Kits recalled for quality standards

    Chicken of the Sea is recalling promotional Genova Meal Kits because products included in the kits were prepared in a home kitchen that did not meet quality standards.

    Product
    Chicken of the Sea Genova Meal Kit; Kits include dry whole wheat pasta, dried basil and parsley, 2 cans of Genova Tuna, pesto, Kalamata olives, sundried tomatoes, dates.
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0920-2021·2021-08-25

    Holle Goat Stage 2 Infant Formula Recalled for Missing FDA Pre-Market Notification

    Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) because required pre-market notifications were not submitted to the FDA and products lack mandatory labeling in English.

    Product
    Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0727-2021·2021-08-25

    Cholestene Capsules Recalled for Marketing Without Approved Application

    High Performance Formulas is recalling Cholestene capsules (red yeast rice supplement, 1200 mg per 2 capsules, 120-count bottles) because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0912-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Missing Pre-Market Notification

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling.

    Product
    HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0752-2021·2021-08-25

    Triamcinolone Acetonide Ointment Mispack Recall by Teligent Pharma

    Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% due to a labeling mispack affecting Lot #16630 with expiration 03/2023. The recall was issued due to incorrect labeling on the product.

    Product
    Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0913-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Missing FDA Premarket Notification and Labeling

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula because required FDA premarket notifications were not submitted and products lack mandatory English labeling as required by federal regulations.

    Product
    HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0725-2021·2021-08-25

    Combipatch Transdermal Patch Recall Due to Stability Failure

    Noven Pharmaceuticals is recalling certain lots of Combipatch (estradiol/norethindrone acetate transdermal system) distributed nationwide because the patches failed stability testing and fell out of specification for shear properties.

    Product
    COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·21188·2021-08-25

    Wee Gallery wooden tray puzzles recalled for choking hazard

    Wee Gallery is recalling Ocean and Safari animal wooden tray puzzles because the octopus and elephant puzzle pieces can break, posing a choking hazard to young children.

    Product
    Ocean and Safari animal wooden tray puzzles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0728-2021·2021-08-25

    Avicel Microcrystalline Cellulose Recall for Out-of-Specification Conductivity

    DuPont Nutrition USA, Inc. is recalling Avicel microcrystalline cellulose (bulk PH101 NF, PH102 NF, PH200 NF) due to out-of-specification conductivity results. The product was distributed nationwide and internationally.

    Product
    Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0870-2021·2021-08-25

    Cotton Blues Cheesecake Strawberry Swirl recalled for incorrect ingredient labeling

    CB Distribution LLC is recalling Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice packages due to incorrect ingredient labeling. The product was distributed to distribution centers in Texas.

    Product
    Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice 6oz plastic container 36 packages per case
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·029-2021·2021-08-24

    Willow Tree Poultry Farm Recalls Chicken Salads and Dips Due to Plastic Contamination

    Willow Tree Poultry Farm is recalling approximately 52,022 pounds of chicken salads and dips that may contain hard white plastic. The products were distributed to nine northeastern states.

    Product
    WILLOW TREE POULTRY FARM, INC. — Willow Tree Poultry Farm Recalls Chicken Salad and Dip Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·21V656000·2021-08-24

    Crane Carrier Recalls 2020-2021 LET2 Trucks for Fuel Hose Leak Risk

    Crane Carrier is recalling 94 LET2 vehicles from 2020-2021 because a fuel hose may leak, increasing the risk of fire if exposed to an ignition source.

    Product
    CRANE CARRIER — CRANE CARRIER, CRANE LET2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V657000·2021-08-24

    PL Custom Emergency Vehicles Recall Rear Brake Line Wear Issue

    PL Custom is recalling 2019 Dodge RAM 5500 emergency vehicles because rear brake lines may wear, risking brake loss and crashes.

    Product
    PL CUSTOM — PL CUSTOM TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21C003000·2021-08-24

    Dorel Maxi-Cosi Pria 85 Child Seat Recall for Tether Anchor Defect

    Dorel is recalling Maxi-Cosi Pria 85 convertible child seats because they may not adequately protect children from head injury if installed with only a lap belt.

    Product
    CHILD SEAT:VEHICLE TETHER ANCHOR recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V655000·2021-08-23

    Reitnouer Recalls 2017-2019 Trailers Due to Steering Arm Detachment Risk

    Reitnouer is recalling 2017-2019 Steer Axle trailers because the steering arm may detach, potentially causing loss of control or road hazards.

    Product
    REITNOUER TRAILERS — REITNOUER TRAILERS REITNOUER TRAILERS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V654000·2021-08-23

    PL Custom Recalls 2021 Ford E-450 Emergency Vehicle for LCD Defect

    PL Custom is recalling one 2021 Ford E-450 emergency vehicle because its LCD display may freeze or fail, potentially delaying emergency efforts.

    Product
    PL CUSTOM — PL CUSTOM TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V652000·2021-08-23

    2021 Ford Explorer and Lincoln Aviator side air bag assembly defect

    Ford and Lincoln are recalling certain 2021 Explorer and Aviator vehicles. Side air bag attachment weld studs may detach during deployment, potentially failing to provide proper protection in a crash.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V650000·2021-08-20

    Chevrolet Bolt EV battery fire hazard recall for defective modules

    General Motors is recalling 2020-2022 Chevrolet Bolt EV and 2022 Bolt EUV vehicles. The high-voltage battery could catch fire when charged to full or nearly full capacity, increasing risk of injury.

    Product
    CHEVROLET — CHEVROLET BOLT EUV, BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V651000·2021-08-20

    2022 Volkswagen Taos Fuel Supply Connector Detachment Recall

    Volkswagen is recalling certain 2022 Taos vehicles because the underhood fuel supply quick-connector may detach from the fuel line, creating fuel leaks that increase risks of engine stalling and fire.

    Product
    VOLKSWAGEN — VOLKSWAGEN TAOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V649000·2021-08-20

    Chevrolet Malibu and Cadillac XT4 seat belt fastener defects

    General Motors is recalling certain 2016-2021 Chevrolet Malibu and 2019-2021 Cadillac XT4 vehicles because rear seat belt retractors may be improperly secured with loose or missing fasteners, potentially affecting safety in a crash.

    Product
    CADILLAC — CADILLAC, CHEVROLET XT4, MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V648000·2021-08-19

    Peterbilt 2021-2022 Commercial Trucks Recalled for Brake System Clearance Defect

    PACCAR is recalling certain 2021-2022 Peterbilt commercial trucks due to insufficient clearance in the Hill Start Assist valve assembly, which may damage the rear brake hose and disable rear braking. Dealers will inspect and repair the assembly free of charge.

    Product
    PETERBILT — PETERBILT 389, 567, 367, 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21776·2021-08-19

    John Deere Compact Utility Tractors Recalled for Wheel Detachment Risk

    Deere & Company is recalling approximately 200 John Deere compact utility tractors (models 4044M, 4044R, 4052M, 4052R, 4066M, 4066R) because rear wheel spacer bolts can be improperly torqued during manufacturing, causing the wheel to fall off and the tractor to overturn.

    Product
    John Deere compact utility tractors
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21775·2021-08-19

    Infant Bath Seats Recalled Due to Drowning Hazard

    Frieyss infant bath seats fail to meet federal safety standards and can tip over while in use, posing a drowning hazard to babies. About 120 units were sold exclusively online at Amazon.com from March through April 2021.

    Product
    Infant Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2192-2021·2021-08-18

    HeartWare HVAD System Recalled Due to Higher Mortality Rates

    Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2191-2021·2021-08-18

    HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure

    Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1153
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2193-2021·2021-08-18

    HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns

    Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2197-2021·2021-08-18

    Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures

    Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.

    Product
    HeartWare HVAD Pump Accessories, REF MCS1753AK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2194-2021·2021-08-18

    HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Implant Kit, REF 1104JP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2195-2021·2021-08-18

    HeartWare HVAD Implant Kit Recalled Over Higher Mortality Rates

    Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.

    Product
    HeartWare HVAD Implant Kit, REF MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2188-2021·2021-08-18

    FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2190-2021·2021-08-18

    HeartWare HVAD heart pump implants recalled for neurological events and mortality

    Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1125
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2196-2021·2021-08-18

    Heartware HVAD ventricular assist device recalled due to mortality risk

    Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.

    Product
    HeartWare HVAD Outflow Graft, REF MCS1725OG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2110-2021·2021-08-18

    Spectrum IQ Infusion System Recalled for Connectivity Errors

    Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.

    Product
    Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2189-2021·2021-08-18

    Heart Pump Device Recalled for Increased Mortality and Device Failure

    Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2021·2021-08-18

    Infusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards

    BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0718-2021·2021-08-18

    Compounded Progesterone Oil Recalled for Non-Sterility Risk

    People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.

    Product
    C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0715-2021·2021-08-18

    Injectable drug recalled due to non-sterility concern

    Med Shop Total Care is recalling morphine-bupivacaine-fentanyl injectable syringes due to non-sterility. The affected lot was distributed in Texas and Puerto Rico.

    Product
    MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0707-2021·2021-08-18

    FDA Recalls Non-Sterile Fentanyl-Bupivacaine-Baclofen Injection

    Med Shop Total Care Inc. is voluntarily recalling one lot of fentanyl-bupivacaine-baclofen injectable solution due to non-sterility concerns. The product was distributed in Texas and Puerto Rico.

    Product
    FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0711-2021·2021-08-18

    Injectable Drug Recall: Non-Sterile Hydromorphone-Bupivacaine-Fentanyl

    Med Shop Total Care is recalling injectable syringes containing hydromorphone, bupivacaine, and fentanyl due to non-sterility concerns. The recall affects products distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0706-2021·2021-08-18

    Fentanyl-Bupivacaine Injectable Recalled for Non-Sterility Risk

    Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.

    Product
    FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0898-2021·2021-08-18

    McCormick Perfect Pinch Italian Seasoning Recalled for Salmonella

    McCormick & Company is recalling McCormick Perfect Pinch Italian Seasoning due to potential Salmonella contamination. Consumers should not consume the affected product.

    Product
    McCormick Perfect Pinch Italian Seasoning 1.31 oz. Plastic Bottles, 36 packages per case; 2.25 oz. Plastic bottles, 6 packages per case
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-0704-2021·2021-08-18

    Injectable Drug Bupivacaine HCL-Baclofen PF Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling a bupivacaine HCL-baclofen PF injectable drug (21 mL syringe, Lot #: 09282020@94) distributed in Texas and Puerto Rico due to non-sterility concerns.

    Product
    BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0709-2021·2021-08-18

    Injectable drug recalled for non-sterility concerns in Texas and Puerto Rico

    Med Shop Total Care is voluntarily recalling injectable hydromorphone HCL-bupivacaine HCL-clonidine HCL due to non-sterility. The recall affects specific lots distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0710-2021·2021-08-18

    Morphine-Bupivacaine Injectable Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling morphine-bupivacaine injectable in prefilled syringes of multiple strengths due to non-sterility. The affected product was distributed to Texas and Puerto Rico.

    Product
    MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2165-2021·2021-08-18

    Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch

    Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.

    Product
    Dose IQ Safety Software used with Spectrum IQ Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0871-2021·2021-08-18

    Dark Chocolate Malt Balls recalled for undeclared peanuts

    DSD Merchandisers is recalling Dark Chocolate Malt Balls because some containers were filled with Dark Chocolate Peanut Butter malt balls instead, creating a risk for consumers with peanut allergies who may not be aware of the peanut content.

    Product
    Dark Chocolate Malt Balls in plastic container; 9 oz./ 255g UPC: 6 5143370179 0 Packed on the same equipment as products that contain milk, eggs, tree nuts, peanuts, wheat and soy. Distributed by DSD Merchandisers, Inc., Livermore, CA 64551
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0900-2021·2021-08-18

    Frank's Red Hot Buffalo Ranch Seasoning Recalled for Salmonella Contamination

    McCormick & Company is recalling Frank's Red Hot Buffalo Ranch Seasoning due to potential Salmonella contamination. The product was distributed to multiple U.S. states and Canada.

    Product
    Frank s Red Hot Buffalo Ranch Seasoning 153g, Plastic Bottles, 36 packages per case
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-0717-2021·2021-08-18

    Hydromorphone HCL-Bupivacaine HCL Injectable Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths distributed in Texas and Puerto Rico due to non-sterility concerns.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5M
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0899-2021·2021-08-18

    McCormick Culinary Italian Seasoning Recalled for Salmonella Risk

    McCormick & Company is recalling McCormick Culinary Italian Seasoning (1.75 lbs. plastic jugs) distributed across multiple U.S. states and Canada due to potential Salmonella contamination.

    Product
    McCormick Culinary Italian Seasoning 1.75 lbs. , Plastic Jugs (Large Plastic Bottles), (3) 3 packages per case.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-0705-2021·2021-08-18

    Injectable drug recalled for non-sterility in Texas and Puerto Rico

    Med Shop Total Care Inc. is recalling a Bupivacaine HCL-Lioresal PF injectable drug due to non-sterility concerns. The recall affects a 41 mL syringe product distributed in Texas and Puerto Rico.

    Product
    BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0712-2021·2021-08-18

    Injectable morphine-hydromorphone-bupivacaine mixture recalled for non-sterility

    Med Shop Total Care Inc. is recalling a compounded injectable pain medication in Texas and Puerto Rico because the product failed to meet sterility standards. The recall affects lot 09292020@64.

    Product
    MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereCPSC·21186·2021-08-18

    Ravin White Arrow Nocks Recalled for Injury Risk

    Ravin Crossbows is recalling white arrow nocks that can fail to engage properly with the bowstring, allowing the crossbow to discharge unexpectedly during re-nocking and causing finger injuries. About 220,000 units are affected.

    Product
    Ravin® white arrow nocks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E076000·2021-08-18

    Palfinger Knuckle Boom Cranes Recalled Due to Base Cracking Risk

    Palfinger is recalling specific Knuckle Boom Cranes because the base may crack, potentially causing the crane to detach from the truck mount.

    Product
    EQUIPMENT:MECHANICAL:BOOM/CRANE/LADDER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0713-2021·2021-08-18

    Morphine-Bupivacaine-Ketamine Injectables Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.

    Product
    MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0716-2021·2021-08-18

    Injectable Drug Recalled for Non-Sterility Risk

    Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0708-2021·2021-08-18

    Injectable Drug Syringes Recalled for Non-Sterility

    Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0714-2021·2021-08-18

    Injectable Drug Sufentanil-Bupivacaine-Baclofen Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling a 41 mL injectable drug combination due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.

    Product
    SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2228-2021·2021-08-18

    Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip

    Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.

    Product
    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-2249-2021·2021-08-18

    Bard Bone Marrow Aspiration Needles Recalled for Incomplete Packaging Seals

    Bard Peripheral Vascular is recalling Illinois Bone Marrow Aspiration/Intraosseous Infusion Needles due to incomplete or open packaging seals that could compromise sterility. Approximately 1,200 devices are affected.

    Product
    TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2021·2021-08-18

    FDA Recalls Blood Culture Identification Panel for False Negative Results

    BioFire Diagnostics is recalling 29 FilmArray Blood Culture Identification Panel kits distributed nationwide due to false negative test results caused by a pouch manufacturing error.

    Product
    FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2021·2021-08-18

    Advance Dx 100 Blood Collection Cards Recalled for Inaccurate Glucose Results

    Advance Dx, Inc. is recalling Advance Dx 100 Blood Collection Cards due to inaccurate blood glucose test results. The recall affects 179,750 cards distributed in Maryland and North Carolina.

    Product
    Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2021·2021-08-18

    Cardiac Sheath Introducer Devices Recalled Due to Size Mislabeling

    Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2246-2021·2021-08-18

    Mislabeled Cutting Electrode May Contain Wrong Electrode Type

    Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.

    Product
    CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kits Recalled for Potential Internal Leaks

    Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2266-2021·2021-08-18

    Hip Implant Component Failure Risk From Inner Taper Fretting Corrosion

    Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2021·2021-08-18

    Biomet Hip Replacement Component Recalled Over Corrosion and Device Failure Risk

    Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2021·2021-08-18

    Biomet Hip Implant System Recalled Due to Potential Fretting Corrosion

    Biomet is recalling the Arcos Modular Revision Hip System component due to potential inner taper fretting corrosion that could lead to device failure requiring surgery. No injuries have been reported.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2021·2021-08-18

    Smith & Nephew Orthopedic Nail May Detach During Surgery

    Smith & Nephew is recalling an orthopedic surgical nail (BHR SQUARE HEADED, catalog #999908) that may detach during surgery. Forty-seven affected units have been distributed worldwide.

    Product
    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2021·2021-08-18

    Hip Replacement Component Recalled for Potential Device Failure Risk

    Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2021·2021-08-18

    Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers

    Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.

    Product
    Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2021·2021-08-18

    Stryker CUB Pediatric Crib distributed to home users instead of healthcare facilities

    Stryker's CUB Pediatric Crib, designed for hospital use by healthcare professionals, was distributed to home users who may not understand the complex instructions and safety procedures required to operate pediatric medical equipment safely.

    Product
    CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2021·2021-08-18

    Prelude SNAP cardiac introducer sheath potentially mislabeled with wrong size

    Merit Medical Systems is recalling Prelude SNAP Splittable Sheath Introducers (10F size) because 7F sheaths may have been packaged with 10F labels. This error affects 760 units in lot I2067768.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2248-2021·2021-08-18

    Bard Jamshidi Evolve Bone Marrow Needle Recall Due to Open Packaging

    Bard recalls Jamshidi Evolve bone marrow needles due to incomplete packaging seals that could compromise sterility. The recall affects 560 devices distributed in the U.S. and internationally.

    Product
    EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2021·2021-08-18

    Transport Stretcher 747 distributed to home users without professional training

    Stryker's Transport Stretcher 747, designed for healthcare facilities, was distributed to home users who may not understand its intended-use instructions. The recall addresses risks from improper use by untrained consumers.

    Product
    Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kit Recalled for Potential Internal Leaks

    Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563
    Category
    Medical Device
    Distribution
    12 states

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