The Recall Desk

Archive

November 2019 recalls

944 recalls were announced in November 2019.

What the numbers show

Critical
50
Severe
405
High
251
Moderate
213
Low
25

Of the 944 recalls this month scored against our rubric, 5% are Critical, 43% are Severe.

Which agencies issued them

701–800 of 944

  • HighFDA (Devices)·Z-0214-2020·2019-11-13

    Philips Recalls Forte Gamma Camera Systems Due to Detector Fall Risk

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2020·2019-11-13

    Western Grab n Go Opti VIPR System Recalled for Control Knob Defect

    Western / Scott Fetzer Company is recalling 6,790 Grab n Go Opti series VIPR systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0131-2020·2019-11-13

    Whole Foods Market White Parkerhouse Rolls Recalled for Undeclared Milk and Eggs

    Whole Foods Market is recalling White Parkerhouse Rolls in Michigan, Wisconsin, and Illinois due to undeclared milk and eggs.

    Product
    Whole Foods Market White Parkerhouse Rolls PLU 49557 NET WT. 0 lb 12 oz (340g) packaged in a clear plastic bag 12 rolls per bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0118-2020·2019-11-13

    Kroger Wild Caught Sockeye Salmon Recalled for Listeria Risk

    Cold Locker Processing LLC is recalling 2,520 lbs of Kroger Wild Caught Sockeye Salmon due to potential Listeria monocytogenes contamination.

    Product
    Kroger Wild Caught Sockeye Salmon Boneless, Frozen, Raw, Skin-on, not ready to eat (NRTE), individually vacuum packed in a 12 oz retail plastic bag. Salmon is a product of USA. The label is read in parts: "***Kroger ***Wild Caught Sockeye Salmon Boneless***INGREDIENTS: SOCKEY
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0133-2020·2019-11-13

    Pride of Iowa Sandwiches Recalls Monster Cheeseburgers Due to Metal Contamination

    Pride of Iowa Sandwiches, Inc. is recalling J. BOS Vending Service Monster Cheeseburgers because the beef patty ingredient was potentially contaminated with foreign metal material.

    Product
    J. BOS Vending Service Monster Cheeseburger, Net Wt. 7.3 oz individually wrapped in plastic, packaged 24 count per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0273-2020·2019-11-13

    Thermo Fisher Recalls Cardinal Health Specimen Containers Due to Plastic Shavings

    Thermo Fisher Scientific is recalling Cardinal Health specimen containers that may contain plastic shavings on threaded surfaces.

    Product
    Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0136-2020·2019-11-13

    Dollar General Recalls Sweet Smiles Dark Chocolate Bars for Undeclared Milk

    Dollar General is recalling Sweet Smiles Select Dark Chocolate with Orange Peel Bars because they may contain undeclared milk, a major food allergen.

    Product
    Sweet Smiles brand Select Dark Chocolate with Orange Peel Bar in 3.5 oz. foil wrapper packaging.
    Category
    Food
    Distribution
    43 states
  • HighNHTSA·19V810000·2019-11-13

    Freightliner M2 Recall: Software Error Causes Unexpected Movement

    Daimler Trucks is recalling 2019 Freightliner Business Class M2 electric vehicles because a software error may cause unexpected movement, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0271-2020·2019-11-13

    Hitachi Scenaria CT System Recalled for Potential Cable Detachment

    Hitachi Medical Systems America Inc is recalling 39 Scenaria Whole-body X-ray CT Systems because cables to the controller unit may not be affixed properly, creating a risk of detachment during scanning.

    Product
    Hitachi Scenaria Whole-body X-ray CT System
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0280-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Communication Error Alarms

    Baxter Healthcare is recalling 336 Prismaflex Control Units with software versions below 7.21 due to communication error alarms that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0296-2020·2019-11-13

    Argon Medical Devices Recalls AHD Luer Lock Caps Due to Seal Defect

    Argon Medical Devices is recalling 49,130 AHD Luer Lock Caps because an incomplete seal may cause loss of sterility.

    Product
    Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2020·2019-11-13

    Zimmer Biomet Recalls Custom Medical Devices Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million custom medical devices because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0134-2020·2019-11-13

    Pride of Iowa Sandwiches Recalled for Potential Metal Contamination

    Pride of Iowa Sandwiches, Inc. is recalling J. BOS Vending Service Gambler sandwiches because an ingredient may contain foreign metal.

    Product
    J. BOS Vending Service Gambler, Net Wt. 9.2 oz individually wrapped in plastic, packaged 24 count per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0285-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-TEST CYP Vials for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-TEST CYP 200mg/ml vials nationwide due to a lack of assurance of sterility.

    Product
    S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2020·2019-11-13

    Teleflex Recalls Babi.Plus Pressure Relief Manifolds for Ventilators

    Teleflex is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because the devices vented gas below the stated pressure.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0135-2020·2019-11-13

    Pride of Iowa Recalls Monster Cheeseburgers Due to Metal Contamination

    Pride of Iowa Sandwiches is recalling J. BOS Vending Service Monster Cheeseburgers because the beef patties used in them may contain foreign metal material.

    Product
    J. BOS Vending Service Monster Cheeseburger on Brioche, Net Wt. 8.5 oz individually wrapped in plastic, packaged 24 count per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0344-2020·2019-11-13

    Centurion Universal Line Full Body Drape Kit Recalled for Packaging Defect

    Centurion Medical Products is recalling 80 units of Universal Line Full Body Drape Kits due to incomplete sterile packaging seals that may compromise product sterility.

    Product
    Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2020·2019-11-13

    Argon Medical Devices Recalls TRI-JECT IV Organizers Due to Seal Defect

    Argon Medical Devices is recalling 49,130 units of TRI-JECT 3 Way IV Administration Organizers because an incomplete seal may cause loss of sterility.

    Product
    Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2020·2019-11-13

    Zimmer Biomet Recalls Periarticular Shoulder Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5,459,583 periarticular shoulder plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2020·2019-11-13

    Medtronic Recalls MiniMed Remote Transmitters for Security Vulnerability

    Medtronic is recalling MiniMed Model 503 Remote Transmitters due to a potential security vulnerability affecting insulin pump accessories.

    Product
    Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0294-2020·2019-11-13

    Argon Medical Devices Hemostasis Valve Recall for Incomplete Pouch Seals

    Argon Medical Devices is recalling Hemostasis Valves because incomplete pouch seals may cause a loss of sterility.

    Product
    Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2020·2019-11-13

    Argon Medical Devices Recalls Double Male LL Adapter Due to Seal Defect

    Argon Medical Devices is recalling Double Male LL Adapters because an incomplete pouch seal may cause a loss of sterility.

    Product
    Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2020·2019-11-13

    Becton Dickinson Recalls MaxZero Extension Sets Due to Fluid Separation

    Becton Dickinson is voluntarily recalling MaxZero Extension Sets with Needle-less Connectors because fluid droplets may separate from the sealed surface after disconnection.

    Product
    MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ8003 MZ9266 MZ9267 MZ9272 MZ9273 MZ9274 MZ9275 MZ9276 MZ9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20708·2019-11-13

    Mystery Ranch Recalls Semi-Automatic Holsters Due to Gun Discharge Risk

    Mystery Ranch is recalling Quick Draw Side Arm Holsters because the retention strap can disconnect, allowing the handgun to fall and unexpectedly discharge.

    Product
    Quick Draw Side Arm Holster - Semi-Auto
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2020·2019-11-13

    Argon Medical Devices Recalls Sterile Adapters Due to Seal Defects

    Argon Medical Devices is recalling specific lots of sterile double female and male luer lock adapters because incomplete pouch seals may compromise sterility.

    Product
    (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2020·2019-11-13

    Argon Medical Devices Recalls Luer Lock Plugs Due to Seal Defect

    Argon Medical Devices is recalling specific lots of Luer Lock Plugs because an incomplete seal may cause a loss of sterility.

    Product
    Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2020·2019-11-13

    Argon Medical Devices Recalls Vascuclamp Vascular Clamps Due to Sterility Risk

    Argon Medical Devices is recalling Vascuclamp radiopaque vascular clamps because an incomplete pouch seal may cause a loss of sterility.

    Product
    (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0202-2020·2019-11-13

    Red Mountain Compounding Recalls S-Atropine Ophthalmic Solution for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Atropine 0.02% ophthalmic solution due to a lack of assurance of sterility. The affected product is a prescription eye drop distributed nationwide.

    Product
    S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2020·2019-11-13

    Insulet Recalls Omnipod DASH Insulin Systems Due to Communication Interruption

    Insulet Corporation is recalling 264 units of the Omnipod DASH Insulin Management System because a communication interruption may cause inaccurate insulin data to be displayed.

    Product
    Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0279-2020·2019-11-13

    Red Mountain Compounding Recalls S-Procaine HCL 2% Buffered Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Procaine HCL 2% Buffered due to a lack of assurance of sterility. The affected prescription products were distributed nationwide.

    Product
    S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0130-2020·2019-11-13

    Schwan's Garlic Herb Shrimp Recalled for Undeclared Milk and Soy Allergens

    Fisherman's Pride Processor is recalling 1,872 units of Schwan's Garlic Herb Shrimp due to undeclared milk and soy lecithin.

    Product
    Schwan's Garlic Herb Shrimp NET WT 16 oz. (1 lb.) Keep Frozen Cook Thoroughly Distributed By: Schwan's Home Service, Inc. Marshall. MN 56258 UPC 052008
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0339-2020·2019-11-13

    Western Grab n Go Opti VIPR System Recalled for Control Knob Defect

    Western / Scott Fetzer Company is recalling 1,287 Grab n Go Opti VIPR oxygen delivery systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·112-2019·2019-11-13

    Creative Food Processing Recalls Raw Chicken Skewers for Undeclared Wheat

    Creative Food Processing is recalling raw chicken skewers because they contain wheat, a known allergen, that is not declared on the label.

    Product
    CREATIVE FOOD PROCESSING — Creative Food Processing Recalls Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0343-2020·2019-11-13

    Western / Scott Fetzer Recalls Grab n Go Opti VIPR Oxygen Systems

    Western / Scott Fetzer is recalling 486 Grab n Go Opti VIPR oxygen systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0290-2020·2019-11-13

    Argon Medical Devices Recalls Stopcocks Due to Incomplete Pouch Seals

    Argon Medical Devices is recalling specific stopcock products because incomplete pouch seals may cause a loss of sterility.

    Product
    (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0122-2020·2019-11-13

    Tuscan Sun Bacon Ranch Chicken Salad Recalled Due to Listeria Risk

    Jumbo Foods, Inc. is recalling Tuscan Sun brand Bacon Ranch Chicken Salad sandwiches because they may be contaminated with Listeria monocytogenes.

    Product
    Bacon Ranch Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01417 4. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior sell
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·19V811000·2019-11-13

    Winnebago Recalls 2017-2020 Motorhomes Due to Electrical Fire Risk

    Winnebago is recalling 2017-2020 Itasca Vista, Sunstar, and Adventurer 35F motorhomes because an improperly mounted electrical connector poses a fire risk if the floor gets wet.

    Product
    WINNEBAGO — WINNEBAGO VISTA, SUNSTAR, ADVENTURER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2020·2019-11-13

    Zimmer Biomet Recalls Trabecular Metal Reverse Shoulder System Implants

    Zimmer Biomet is recalling Trabecular Metal Reverse Shoulder System implants because non-highly polished components may adhere to the packaging bag.

    Product
    Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 0043421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0309-2020·2019-11-13

    Zimmer Biomet Recalls Tibia Lock Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling Prox Lat Tib Lock Plates and Dist Med Tib Lock Plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 4723570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0213-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled for Detector Fall Hazard

    Philips is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded vertically to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0312-2020·2019-11-13

    Zimmer Biomet Recalls Universal Locking Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million Universal Locking Plates because non-highly polished implants may adhere to the packaging bag.

    Product
    Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0307-2020·2019-11-13

    Zimmer Biomet Recalls Tibial Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million tibial plates because non-highly polished implants may adhere to the packaging bag.

    Product
    Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0269-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS K+ Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS K+ Slides because a mechanical failure may cause intermittent slide dispense issues.

    Product
    VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2020·2019-11-13

    Zimmer Biomet Recalls Hip Joint Replacement Systems Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million hip joint replacement systems because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248 00151506448 00151506648 00400500060 00401000038 00401000040 00401000041 0040100004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2020·2019-11-13

    Zimmer Biomet Recalls BF Humeral Stems Due to Packaging Adhesion

    Zimmer Biomet is recalling BF Humeral Stems because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 0043
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0266-2020·2019-11-13

    Datascope Recalls Low Level Output Cables for Intra-Aortic Balloon Pumps

    Datascope Corp. is recalling seven low level output cables for intra-aortic balloon pumps because they were packaged with incorrect cables.

    Product
    Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0322-2020·2019-11-13

    Zimmer Biomet Recalls Various Surgical Screws and Reamers

    Zimmer Biomet is recalling various surgical screws and reamers because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0164-2020·2019-11-13

    Full Moon Fish Tuna Steaks Recalled for Incorrect Label Information

    ALFA INTERNATIONAL SEAFOOD INC is recalling Full Moon Fish Tuna Steaks because the labels contain incorrect manufacturer numbers, pack dates, and expiration dates.

    Product
    Full Moon Fish Tuna Steaks, Skinless, Boneless, IVP, Size: 8 oz, Net Weight 5 lbs
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0148-2020·2019-11-13

    Citrus World Recalls Disney Donald Duck Kiwi Strawberry Juice for Mold

    Citrus World, Inc. is recalling Disney Donald Duck Kiwi Strawberry Flavored Four Juice Cocktail due to potential mold contamination.

    Product
    Disney Donald Duck Kiwi Strawberry Flavored Four Juice Cocktail 20 OZ
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0301-2020·2019-11-13

    Zimmer Biomet Recalls Coorad Morrey Total Elbow Implants

    Zimmer Biomet is recalling Coorad Morrey Total Elbow implants because non-highly polished components may adhere to the packaging bag.

    Product
    Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 32855510843 32855510844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0283-2020·2019-11-13

    Randox Liquid Protein Calibrators Recalled for Rheumatoid Factor Value Adjustment

    Randox Laboratories is recalling 100 kits of Liquid Protein Calibrators because the assigned value for Rheumatoid Factor over-recovered against the reference material. The calibrator values have been adjusted to re-align to the reference material.

    Product
    Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0321-2020·2019-11-13

    Zimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion

    Zimmer Biomet is recalling various knee systems because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0308-2020·2019-11-13

    Zimmer Biomet Recalls Periarticular Femur Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5,459,583 periarticular femur plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 00234700216 00234700218 00234703104 00234703106 00234703108 00234703204 002347
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0192-2020·2019-11-13

    Basic Reset CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 598 bottles of CBD Reset 750 True Full Spectrum Cinnamon because the product was marketed without an approved NDA or ANDA.

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0323-2020·2019-11-13

    Zimmer Biomet Recalls Limb Salvage Arthroplasty Devices Due to Packaging Issue

    Zimmer Biomet is recalling 5,459,583 limb salvage arthroplasty devices because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0268-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because the anti-backup platen may fail to advance, causing intermittent slide dispense issues.

    Product
    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0304-2020·2019-11-13

    Zimmer Biomet Recalls NCB Periprosthetic Proximal Femoral Plates

    Zimmer Biomet is recalling NCB Periprosthetic Proximal Femoral Plates because non-highly polished implants may adhere to the packaging bag.

    Product
    NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 020226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2020·2019-11-13

    Zimmer Biomet Recalls Sidus Stem-Free Shoulder Humeral Head Implants

    Zimmer Biomet is recalling Sidus Stem-Free Shoulder Humeral Head implants because non-highly polished units may adhere to the LDPE bag.

    Product
    Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0329-2020·2019-11-13

    Zimmer Biomet Recalls Temporary Surgical Devices Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million temporary surgical devices because non-highly polished implants may adhere to the packaging bag.

    Product
    Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 4722580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0326-2020·2019-11-13

    Zimmer Biomet Recalls Various Fixation Systems and Accessories

    Zimmer Biomet is recalling various fixation systems and accessories because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 0011810
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0334-2020·2019-11-13

    Zimmer Biomet Recalls Metasul Taper Liners Due to Packaging Adhesion

    Zimmer Biomet is recalling Metasul Taper Liners because non-highly polished implants may adhere to the LDPE bag. The recall covers devices manufactured prior to January 2014.

    Product
    Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 00877001240 00877001340 00877001440 00877001540 00877001640 00877001740 00877001840 00877001940 00877002040 00877002140 00877002240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2020·2019-11-13

    Zimmer Biomet Recalls Fitmore Hip Stems Due to Packaging Adhesion

    Zimmer Biomet is recalling Fitmore Hip Stems because non-highly polished implants may adhere to the LDPE bag used in previous packaging configurations.

    Product
    Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205 01005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0310-2020·2019-11-13

    Zimmer Biomet Recalls Distal Lateral Femoral Locking Plates

    Zimmer Biomet is recalling 5,459,583 sterile distal lateral femoral locking plates because non-highly polished implants may adhere to the packaging bag.

    Product
    DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2020·2019-11-13

    Zimmer Biomet Recalls Periarticular Locking Elbow Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million periarticular locking elbow plates because non-highly polished implants may adhere to the packaging bag.

    Product
    Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 47235800611 47235800615 47235800619 47235800705 47235800711 47235800715 47235800803 47235800805 47235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0340-2020·2019-11-13

    Western / Scott Fetzer Recalls Grab n Go Opti VIPR Oxygen Systems

    Western / Scott Fetzer is recalling 143,164 Grab n Go Opti VIPR oxygen systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0315-2020·2019-11-13

    Zimmer Biomet Recalls Peri Dist Volar/Dorsal T/Dorsal Delta Radial Implants

    Zimmer Biomet is recalling specific wrist implants because non-highly polished devices may adhere to the packaging bag.

    Product
    PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0193-2020·2019-11-13

    Basic Reset CBD Product Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 98 bottles of CBD Reset 750 because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0338-2020·2019-11-13

    Zimmer Biomet Recalls Cable Buttons for Polyaxial Locking Plates

    Zimmer Biomet is recalling cable buttons for NCB Polyaxial Locking Plates because non-highly polished implants may adhere to the packaging bag.

    Product
    cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0119-2020·2019-11-13

    Casablanca Non-Pareils Sprinkles Recalled for Prohibited Food Colors

    Spice N' More Corp. is recalling Casablanca Non-Pareils Sprinkles because the product contains prohibited food colors Ponceau 4R and FD&C Red 2.

    Product
    Casablanca brand Non-Pareils Sprinkles in 12oz clear plastic container ING: sugar, dextrin, hum Arabic, glycerin, titanium dioxide, magnesirm silicate, carnauba wax, FD&C colors yellow #5, yellow #6, red #40, blue #1, red #3 tapioca starch & glucose powder Packed by : Spice N' M
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0282-2020·2019-11-13

    Randox Rheumatoid Factor Standard Recalled for Value Adjustment

    Randox Laboratories is recalling 17 Rheumatoid Factor Standard kits because assigned values over-recovered against reference material. The values have been adjusted to align with the reference standard.

    Product
    Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0336-2020·2019-11-13

    Zimmer Biomet Recalls Ceramic Femoral Heads Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million ceramic femoral heads because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0187-2020·2019-11-13

    Basic Reset Earth Wash Cleaner Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 949 bottles of Earth Wash Cleaner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0303-2020·2019-11-13

    Zimmer Biomet Recalls NCB Proximal Lateral Tibia Implants

    Zimmer Biomet is recalling NCB Proximal Lateral Tibia implants because non-highly polished devices may adhere to the packaging bag.

    Product
    NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2020·2019-11-13

    Zimmer Biomet Recalls Prox Lat Humeral Lock Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling Prox Lat Humeral Lock Plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0346-2020·2019-11-13

    LivaNova VNS Therapy System Recall Due to Impedance Measurement Shift

    LivaNova is recalling VNS Therapy System generators because a timing change causes reported lead impedance values to be higher than previous models, shifting normal ranges relative to existing thresholds.

    Product
    The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0328-2020·2019-11-13

    Zimmer Biomet Recalls Various Fixation Systems and Accessories

    Zimmer Biomet is recalling various fixation systems and accessories because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 0022400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0305-2020·2019-11-13

    Zimmer Biomet Recalls ZPLP Fibular Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling ZPLP Fibular Plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0270-2020·2019-11-13

    Pega Medical Recalls SCFE Knobs for Driver Due to Screw Loosening Risk

    Pega Medical Inc. is recalling 31 SCFE Knobs for Driver because screws may loosen during ultrasonic cleaning and fall out.

    Product
    SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0286-2020·2019-11-13

    Biomedical Polymers Recalls Hemo-Drop Blood Dispensers Due to Metal Cannula Defect

    Biomedical Polymers, Inc. is recalling 108,000 Hemo-Drop Blood Dispensers because the metal cannula may break or fail to pierce the specimen tube.

    Product
    Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0197-2020·2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0330-2020·2019-11-13

    Zimmer Biomet Recalls Connection Screws for NCB Plates

    Zimmer Biomet is recalling 5,459,583 Connection Screws for NCB Plates because non-highly polished implants may adhere to the LDPE bag.

    Product
    Connection Screw for NCB Plate, Item No. 0202266002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2020·2019-11-13

    Zimmer Biomet Recalls Cable-Ready Short and Long GTR Implants

    Zimmer Biomet is recalling Cable-Ready Short and Long GTR implants because non-highly polished units may adhere to the LDPE bag.

    Product
    CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0285-2020·2019-11-13

    Becton Dickinson Recalls 13 Fr Trialysis Catheters Due to Packaging Error

    Becton Dickinson is recalling 75 units of 13 Fr Trialysis Catheters because a portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.

    Product
    13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0189-2020·2019-11-13

    Basic Reset Nuovi Skin Toner Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 1,000 bottles of Nuovi Skin Toner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0267-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because an anti-backup platen failure may cause intermittent slide dispense issues.

    Product
    VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0188-2020·2019-11-13

    Basic Reset Recalls Miracle Facelift Masque for Lack of FDA Approval

    Basic Reset Inc. is recalling Miracle Facelift Masque because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0319-2020·2019-11-13

    Zimmer Biomet Recalls CLS Brevius Stem Kinectiv Hip Prostheses

    Zimmer Biomet is recalling CLS Brevius Stem Kinectiv hip prostheses because non-highly polished implants may adhere to the packaging bag.

    Product
    CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0194-2020·2019-11-13

    Basic Reset CBD Product Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 391 bottles of CBD Reset 2400 because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0325-2020·2019-11-13

    Zimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion

    Zimmer Biomet is recalling various knee systems because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0272-2020·2019-11-13

    Thermo Fisher Recalls Cardinal Health Sterile Specimen Containers

    Thermo Fisher Scientific is recalling Cardinal Health sterile specimen containers that may contain plastic shavings on threaded surfaces.

    Product
    Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0195-2020·2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0337-2020·2019-11-13

    Zimmer Biomet Recalls Cephalomedullary Nails Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million cephalomedullary nails because non-highly polished implants may adhere to the packaging bags.

    Product
    Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 47249318210 47249318211 47249318213 47249318214 47249318309 47249318310 47249
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0287-2020·2019-11-13

    Biomedical Polymers Recalls Manual Diff Droppers Due to Cannula Failure

    Biomedical Polymers is recalling Manual Diff Droppers because the metal cannula may break or fail to pierce blood specimen tubes.

    Product
    Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0331-2020·2019-11-13

    Zimmer Biomet Recalls NCB Straight Narrow Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling NCB Straight Narrow Plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018
    Category
    Medical Device
    Distribution
    Distributed nationwide

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