The Recall Desk

Archive

January 2023 recalls

460 recalls were announced in January 2023.

What the numbers show

Critical
4
Severe
46
High
307
Moderate
103

Of the 460 recalls this month scored against our rubric, 1% are Critical, 10% are Severe.

Which agencies issued them

401–460 of 460

  • ModerateFDA (Devices)·Z-0852-2023·2023-01-11

    Medical Device Recall: ETEST Meropenem/Vaborbactam Due to Storage Temperature Excursion

    Biomerieux is recalling 6 units of ETEST Meropenem/Vaborbactam susceptibility test kits (Batch 1008848690) distributed nationwide because they were stored outside specified temperature and time ranges, preventing guarantee of product performance.

    Product
    ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2023·2023-01-11

    Diagnostic Test Kit Recalled Due to Exceeded Storage Conditions

    Biomerieux Inc is recalling API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.

    Product
    API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0802-2023·2023-01-11

    CHROMID MRSA Culture Medium Recalled for Storage Temperature Exceedance

    Biomerieux Inc is recalling PPM CLINICAL CHROMID MRSA 20 PLT diagnostic culture media (84 units) due to temperature and time exceedance during storage that may compromise product performance.

    Product
    PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0849-2023·2023-01-11

    Microbiological susceptibility test strips recalled for temperature and time excursion

    Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.

    Product
    ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2023·2023-01-11

    PPM Clinical Chromid VRE Culture Media Recalled for Storage Excursion

    Biomerieux is recalling PPM Clinical Craponne Chromid VRE culture media because storage conditions (temperature and time) exceeded specifications. Batch 1009540400 was distributed nationwide in the United States.

    Product
    PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0820-2023·2023-01-11

    FDA Recalls ETEST Clinical Benzylpenicil Test Due to Storage Excursion

    Biomerieux Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 was distributed nationwide.

    Product
    ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0832-2023·2023-01-11

    Biomerieux Recalls BIOBALL K.RHIZOPHILA Diagnostic Kits Due to Storage Failure

    Biomerieux Inc recalls BIOBALL K.RHIZOPHILA diagnostic kits (batch 7408) due to exceeded temperature and time storage conditions that may compromise product performance.

    Product
    BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0863-2023·2023-01-11

    ETEST Clinical Colistin Test Product Recalled Due to Storage Conditions

    Biomerieux Inc is recalling ETEST Clinical Colistin diagnostic test products because storage conditions exceeded safe parameters, making product performance unreliable. Affected batches were distributed nationwide.

    Product
    ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0872-2023·2023-01-11

    Biomerieux Culture Media Recalled Due to Temperature and Time Excursions

    Biomerieux Inc is recalling diagnostic culture media because temperature and time storage conditions exceeded acceptable specifications, which means product performance cannot be guaranteed.

    Product
    PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0777-2023·2023-01-11

    Beckman Coulter IRISpec glucose control false positive results with urine chemistry strips

    Beckman Coulter is recalling IRISpec glucose control due to intermittent false positive results when used with specific urine chemistry strips. The recall may affect laboratory test accuracy.

    Product
    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0842-2023·2023-01-11

    PPM Clinical CHROMID MRSA diagnostic product recalled due to storage condition exceedance

    Biomerieux Inc is recalling a batch of PPM Clinical CHROMID MRSA diagnostic medium (catalog 414524) after storage temperatures and timeframes exceeded specification, preventing performance guarantees.

    Product
    PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0816-2023·2023-01-11

    Clinical Reagent Vitek MS-FA Recalled Due to Storage Condition Violations

    Biomerieux is recalling VITEK MS-FA clinical reagent due to storage condition violations that degrade product performance. The recall affects 29 units distributed nationwide.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0855-2023·2023-01-11

    Medical Device Reagent Recalled for Temperature Storage Condition Failure

    Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.

    Product
    GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2023·2023-01-11

    PPM Lombard R2A Laboratory Medium Recalled for Exceeded Storage Conditions

    Biomerieux Inc is recalling PPM Lombard R2A medium products (lot 1009527290) because storage conditions exceeded acceptable parameters, compromising product performance. Approximately 20 units distributed nationwide in the United States.

    Product
    PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0096-2023·2023-01-11

    Prochlorperazine Maleate tablets recalled for subpotency: out of specification at stability testing

    Jubilant Cadista Pharmaceuticals recalls 14,061 bottles of Prochlorperazine Maleate 5mg tablets nationwide due to subpotency. The medication failed quality testing at 18 months and contains less active ingredient than specified.

    Product
    PROCHLORPERAZINE MALEATE — PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0850-2023·2023-01-11

    Biomerieux Recalls VITEK 2 Diagnostic Test Kit Due to Storage Conditions

    Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.

    Product
    VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0821-2023·2023-01-11

    ETEST Ceftriaxone Antibiotic Test Strips Recalled for Storage Condition

    Biomerieux is recalling ETEST Clinical Ceftriaxone test strips nationwide because storage temperature and time conditions were exceeded, which may affect product analytical performance.

    Product
    ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0826-2023·2023-01-11

    Levofloxacin ETEST Clinical Test Recalled for Improper Storage Conditions

    Biomerieux Inc. is recalling 7 units of ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Batch 1009240000) due to temperature and time storage condition violations that prevent guarantee of product performance.

    Product
    ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0805-2023·2023-01-11

    Bioball Fungal Reference Standard Recalled for Temperature Storage Issues

    Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.

    Product
    BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0806-2023·2023-01-11

    Biomerieux BIOBALL B.SPIZIZENII culture products recalled for storage failure

    Biomerieux is recalling BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions were exceeded, and product performance cannot be guaranteed.

    Product
    BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2023·2023-01-11

    Laboratory Testing Product Recall Due to Temperature Storage Excursion

    Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers due to storage temperature and time excursions that degrade product performance. Affected units cannot guarantee reliable testing results.

    Product
    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0825-2023·2023-01-11

    ETEST Clinical Imipenem Susceptibility Test Kits Recalled Due to Storage Deviation

    Biomerieux Inc. is recalling ETEST Clinical Imipenem IP 32 susceptibility test kits nationwide because temperature and time storage conditions were exceeded, which may affect product performance.

    Product
    ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2023·2023-01-11

    API NIT1 NIT2 Reagents Recalled Due to Improper Storage Conditions

    Biomerieux is recalling API NIT1 NIT2 Reagents (Catalog 70442, Batch 1009326520) distributed nationwide due to storage conditions that exceeded temperature and time parameters, preventing guaranteed product performance.

    Product
    API NIT1 NIT2 REAGENTS, CATALOG 70442
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2023·2023-01-11

    Biomerieux BIOBALL P.AERUGINOSA Quality Control Product Recalled for Temperature Excursion

    Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.

    Product
    BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2023·2023-01-11

    VITEK 2 BCL Test Kit recalled for storage condition violations

    A batch of VITEK 2 Reagent BCL Test Kit from Biomerieux Inc is being recalled because storage conditions were exceeded, and product performance cannot be guaranteed.

    Product
    VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0867-2023·2023-01-11

    Biomerieux VIDAS Estradiol II Test Systems Recalled for Storage Condition Exceedance

    Biomerieux Inc is recalling VIDAS Estradiol II 60 Tests (Catalog 30431-01, Batch 1009378680) distributed nationwide after temperature and time storage conditions were exceeded, potentially compromising test reliability.

    Product
    VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0804-2023·2023-01-11

    C. difficile diagnostic kit recalled due to storage temperature deviation

    Biomerieux is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test performance.

    Product
    PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0903-2023·2023-01-11

    Quality Control Material Potency Decline Causes Out-of-Range Laboratory Results

    Randox Laboratories recalls a quality control product (PS2682) because Rheumatoid Factor concentration has declined, causing out-of-range quality control results and delayed laboratory test reporting.

    Product
    Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0215-2023·2023-01-11

    PROPAL Hass Avocados recalled for pesticide contamination exceeding limits

    Four Seasons Produce has recalled PROPAL Hass Avocados for containing pesticide residue that exceeds federal tolerance limits. Affected bags were distributed to consignees in New Jersey and Pennsylvania.

    Product
    PROPAL, Hass Avocados , Bag of 6 pieces, Green net with green plastic film, 11 bags per case.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0800-2023·2023-01-11

    VIDAS Quality Control Product Recalled for Storage Condition Deviation

    Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.

    Product
    VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2023·2023-01-11

    VIDAS HCG 60 Clinical Test Kits Recalled for Exceeded Storage Conditions

    Biomerieux Inc is recalling VIDAS HCG 60 test kits because storage conditions were exceeded, which cannot guarantee product performance. No illnesses or injuries have been reported.

    Product
    VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0839-2023·2023-01-11

    Biomerieux CHROMID CARBA Laboratory Product Recalled Due to Storage Condition Violations

    Biomerieux Inc is recalling CHROMID CARBA laboratory products nationwide because storage conditions exceeded acceptable temperature and time ranges. The company cannot guarantee product performance.

    Product
    PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0791-2023·2023-01-11

    VITEK 2 Reagent Test Kit Recalled Due to Storage Temperature and Time Exceedance

    Biomerieux Inc is recalling VITEK 2 Reagent NH Test Kit units nationwide because they were stored outside proper temperature and time parameters. Product performance cannot be guaranteed.

    Product
    VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0844-2023·2023-01-11

    Laboratory Culture Medium Recalled Due to Storage Condition Failure

    Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar because storage conditions exceeded acceptable temperature and time parameters, potentially compromising product performance.

    Product
    PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0836-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GN79 Reagent Test Kit for Temperature Excursion

    Biomerieux Inc. is recalling 310 units of the VITEK 2 REAGENT AST-GN79 TEST KIT (batches 5992201403 and 5992253503) nationwide because temperature and time conditions exceeded specified ranges, preventing guaranteed product performance.

    Product
    VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalCPSC·23088·2023-01-09

    Fisher-Price Recalls 4.7 Million Rock 'n Play Sleepers Due to Infant Deaths

    Fisher-Price is recalling approximately 4.7 million Rock 'n Play Sleepers after at least 8 deaths were reported following the initial April 2019 recall announcement. Infants have died after rolling from their back to their stomach or side while unrestrained.

    Product
    All models of Rock 'n Play Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalCPSC·23089·2023-01-09

    Kids2 Rocking Sleepers Recalled After 15 Infant Deaths

    Kids2 is recalling approximately 694,000 Rocking Sleepers after 15 infant fatalities were reported. Infants died after rolling from their back to their stomach or side while unrestrained.

    Product
    All models of Kids2 Rocking Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V002000·2023-01-06

    Triple E Recalls 2021-2023 Unity Motorhomes Due to Electrical Fire Risk

    Triple E is recalling 2021-2023 Unity motorhomes because a battery disconnect switch may contact the fridge frame, causing a short circuit and increasing fire risk.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23720·2023-01-05

    Polaris Sportsman and Scrambler 1000 S ATVs recalled for fire hazard

    Polaris is recalling certain 2020–2023 Sportsman and Scrambler 1000 S all-terrain vehicles because electrostatic discharge can ignite fuel during refueling, creating a fire hazard. The company has received 16 reports of fires, including one personal injury.

    Product
    Model Year 2020-2023 Sportsman 1000 S and Scrambler 1000 S All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V001000·2023-01-05

    Volvo Recalls V60CC, XC60, and XC90 Models for Steering Gear Defect

    Volvo is recalling 2019-2022 V60CC, XC60, and XC90 vehicles because a screw in the steering gear could cause the wheel to lock up, increasing crash risk.

    Product
    VOLVO — VOLVO V60CC, XC60, XC90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23086·2023-01-05

    Quality Bicycle Products Carbon Handlebars and Bicycles Injury Hazard

    Quality Bicycle Products is recalling carbon handlebars and bicycles because the handlebars can crack where brake and shift levers are installed, posing a crash and injury risk. The company has received 37 reports of cracking but no injuries have been reported.

    Product
    Bicycle handlebars and bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23085·2023-01-05

    P.J. Salvage Children's Pajamas Recalled for Flammability Hazard

    P.J. Salvage is recalling about 2,650 children's pajama sets that fail to meet federal flammability standards for sleepwear, posing a risk of burn injuries to children.

    Product
    Children's pajamas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0212-2023·2023-01-04

    Lukai sweetened jujube products recalled for undeclared sulfites

    Lukai sweetened jujube products are recalled because they contain undeclared sulfites at 17.9 mg per serving. This allergen poses a risk to consumers with sulfite sensitivity.

    Product
    "Lukai sweetened jujube"; 8.3 ounces; red and yellow packaging; back panel states: "Name: Ejiao dates; Ingredients: a nuclear-free golden jujube, donkey-hide gelatin, sugar, honey, maltose, citric acid; Consumption methods: open bags of ready-to-eat, soup, making cakes; Shelf li
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-0208-2023·2023-01-04

    Favorina Advent Calendar recalled for potential Salmonella contamination

    Lidl US Trading is recalling Favorina Advent Calendar due to potential Salmonella contamination. Approximately 10,524 units were distributed throughout the United States.

    Product
    Favorina Advent Calendar NET WT. 8.4OZ (240g) Premium Chocolate with a Creamy Filling UPC 4056489516965
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0211-2023·2023-01-04

    Phil's Power Pancakes recalled due to undeclared wheat allergen

    Phil's Power Pancakes are being recalled because they contain wheat that is not listed on the label. Consumers with wheat allergies who have purchased this product should not consume it.

    Product
    Phil's Power Pancakes 5 oz. individually wrapped units 5 varieties, including (Chocolate Hempseed, Cranberry, Raspberry, Mango, and Date) UPC: 8 3765448372 5
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0092-2023·2023-01-04

    Hand Sanitizer Recalled for Excess Chemical Impurities in Manufacturing

    NCH Life Sciences LLC is recalling hand sanitizer products containing excess acetal and acetaldehyde impurities due to manufacturing deviations. The recall affects 2.5 and 55-gallon bottles distributed nationwide in the US and Canada.

    Product
    Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgat
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2023·2023-01-04

    Dual-Trak Clavicle Screws recalled: distributed without FDA pre-market clearance

    Acumed LLC is recalling 7,498 units of Dual-Trak Clavicle Screws distributed worldwide without FDA pre-market clearance. These orthopedic surgical screws were marketed without required regulatory approval.

    Product
    Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2023·2023-01-04

    Orthopedic Compression Screws Distributed Without FDA Pre-Market Clearance

    Acumed LLC recalled AcuTwist Acutrak Compression Screws (80,805 units) distributed without FDA pre-market clearance. The devices lack FDA evaluation for safety and effectiveness.

    Product
    AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2023·2023-01-04

    Ganciclovir injection vials contain mislabeled cladribine vials in cartons

    Hikma Pharmaceuticals recalled Ganciclovir for Injection due to a labeling error where one vial per carton was mislabeled as Cladribine Injection, creating a risk of incorrect medication administration.

    Product
    GANCICLOVIR — GANCICLOVIR (GANCICLOVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2023·2023-01-04

    Pilling Wecksorb Cylindrical Sponges recalled due to compromised sterility

    TELEFLEX LLC recalled 1,000 units of Pilling Wecksorb Cylindrical Sponges (Lot 22B0395) because certain lots were not irradiated to eliminate pyronema, potentially compromising sterility. No illnesses have been reported.

    Product
    Pilling Wecksorb Cylindrical Sponges
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0771-2023·2023-01-04

    Remington Medical Automatic Cutting Needle Stylet Longer Than Specified

    Remington Medical is recalling 290 Automatic Cutting Needles with lot number 2224920 because the stylet is longer than specified on the label. Affected units were distributed in NC, WV, CA, PA, AL, and TX.

    Product
    Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-0091-2023·2023-01-04

    Glycopyrrolate 1 mg Tablets Recalled for Failed Impurity Specifications

    AVKARE LLC is recalling Glycopyrrolate 1 mg tablets distributed nationwide due to failed quality specifications involving unknown impurities. The recall affects 1,237 cartons.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23E001000·2023-01-04

    Adventurer Recalls 2021-2022 Truck Bed Campers Due to Propane Leak Risk

    Adventurer LP is recalling 2021-2022 truck bed campers because improper thread depth on LPG tank service valves may cause propane leaks, increasing fire risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0209-2023·2023-01-04

    Shirakiku Premium Fish Sausage recalled for undeclared bovine collagen casing

    Wismettac Asian Foods recalls Shirakiku Fish Sausage due to undeclared collagen (bovine dermis) casing. Approximately 4,780 units were distributed across multiple U.S. states.

    Product
    Premium Quality Shirakiku Fish Sausage Original Net wt. 9.8 oz. (280g) UPC 074410366414 Ingredients: Fish meat (bream, sugar, sodium tripolyphosphate, wheat starch, corn oil, less than 1.5% of salt, soy protein, sugar, maltodextrin, onion powder, garlic powder, yeast extract, d
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Food)·F-0213-2023·2023-01-04

    XO Marshmallow Banana Puddin' OMG Recalled Due to Missing Product Label

    XO Marshmallow Limited Edition Banana Puddin' OMG is being recalled for missing product labels on packaging. The recall affects 526 retail units distributed in 27 U.S. states and internationally.

    Product
    XO Marshmallow Limited Edition: Banana Puddin' OMG (Ooey Marshmallow Goodness), 12oz. marshmallow fluff, 4 12oz. retail units per case
    Category
    Food
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0093-2023·2023-01-04

    Timolol Maleate Ophthalmic Solution recalled for failed stability specifications

    Apotex Corp. is recalling Timolol Maleate Ophthalmic Solution 0.5% (lot TA4844) nationwide due to failed stability specifications showing excessive weight loss that may affect medication potency.

    Product
    Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0768-2023·2023-01-04

    Acumed Acutrak 2 Bone Screws Recalled for Distribution Without FDA Clearance

    Acumed is recalling Acutrak 2 bone screw products distributed without FDA pre-market clearance. Healthcare providers should contact Acumed or the FDA for guidance regarding use and management of these devices.

    Product
    Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0767-2023·2023-01-04

    Acutrak Bone Screws and Fusion Devices Recalled for Lack of FDA Pre-Market Clearance

    Acumed LLC is recalling Acutrak bone screws and fusion devices distributed without FDA pre-market clearance. Patients should contact their healthcare provider for guidance.

    Product
    Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S 45.0mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0210-2023·2023-01-04

    Premium Shirakiku Fish Sausage recalled for undeclared bovine collagen casing

    Wismettac Asian Foods is recalling Premium Quality Shirakiku Fish Sausage Jalapeno because the casing contains undeclared bovine collagen. The product was distributed across 23 U.S. states.

    Product
    Premium Quality Shirakiku Fish Sausage Jalapeno Net wt. 9.8 oz. (280g) UPC 074410366421 Ingredients: Fish meat (bream, sugar, sodium tripolyphosphate, wheat starch, corn oil, less than 1.5% of salt, soy protein, sugar, maltodextrin, onion powder, garlic powder, yeast extract, d
    Category
    Food
    Distribution
    23 states

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