The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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12051–12075 of 40112

  • HighFDA (Devices)·Z-1568-2022·2022-08-31

    Servo-air Ventilator Systems Lack Required Stability Warning Markings

    Getinge is recalling Servo-air Ventilator Systems because they lack required warning markings about stability risks when stationary. A total of 102 units were distributed in the US; 13,750 units were distributed internationally.

    Product
    Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2022·2022-08-31

    ABX PENTRA Creatinine Reagent Recalled Due to Temperature Excursion Exposure

    Mckesson Medical-Surgical is recalling ABX PENTRA Creatinine reagent due to facility temperature excursions (June-August 2021) that may have impacted product effectiveness. Affected lots were received nationwide between June 1 and September 30, 2021.

    Product
    a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2022·2022-08-31

    Medical Sponges Recalled for Temperature Exposure During Storage

    Mckesson Medical-Surgical is recalling MetriSponge cleaning sponges due to facility temperature excursions that may have compromised product effectiveness during storage and delivery between June and August 2021.

    Product
    METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2022·2022-08-31

    Alere Fertility Test Pregnancy Test Kits Recalled Due to Temperature Damage

    Alere Fertility Test pregnancy test kits distributed in the US have been recalled because temperature excursions during storage may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.

    Product
    a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2022·2022-08-31

    Medical Lubricating Jelly Recalled Due to Temperature Excursions During Storage

    Mckesson Medical-Surgical is recalling Fisher Scientific Aseptic Control Lubricating Jelly due to temperature excursions from June–August 2021 that may have reduced product effectiveness.

    Product
    FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2022·2022-08-31

    Boston Scientific Guide Catheter Distributed With Wrong Tip Curve

    Boston Scientific recalled 184 guide catheters manufactured with the wrong tip curve specification. Affected devices were distributed to Greece, France, Germany, Italy, Brazil, South Korea, and Russia, but not the U.S.

    Product
    Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1584-2022·2022-08-31

    Surgical Hemostatic Matrix Recalled Due to Temperature Exposure During Storage

    Mckesson is recalling Ethicon SURGIFLO Hemostatic Matrix Kit due to temperature excursions during storage that may have reduced product effectiveness. Affected units were distributed nationwide between June and September 2021.

    Product
    Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2022·2022-08-31

    Alcon Contact Lens Solutions Recalled for Temperature Exposure During Storage and Transit

    Multiple Alcon contact lens solutions were recalled due to facility temperature excursions during storage and transit that may have reduced product effectiveness. Affected products include Clear Care and Opti Free Replenish solutions distributed nationwide between June and September 2021.

    Product
    a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2022·2022-08-31

    Cadwell Disposable Ground Electrodes Recalled Due to Temperature Exposure

    Cadwell Disposable Ground Electrodes may have reduced effectiveness due to facility temperature excursions between June and August 2021. All units distributed nationwide received between June 1 and September 30, 2021 are affected.

    Product
    Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2022·2022-08-31

    Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Risk

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier. The product was distributed nationwide and internationally.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2022·2022-08-31

    Baxter DISCPAC Syringe Tip Caps recalled for packaging sterility concerns

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failures that could compromise the sterile barrier on 10,140 units distributed worldwide.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2022·2022-08-31

    MedSource IV Start Kit Recalled for Temperature-Related Effectiveness Loss

    McKesson is recalling MedSource IV Start kits due to facility temperature excursions that may have compromised product effectiveness. Affected units were received between June and September 2021.

    Product
    MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2022·2022-08-31

    Baxter DISCPAC Syringe Tip Caps Recalled for Potential Sterile Barrier Failure

    Baxter is recalling DISCPAC Syringe Tip Caps due to potential packaging defect that may not maintain sterile barrier. The recall affects 8,500 units distributed worldwide.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1589-2022·2022-08-31

    Drugs of Abuse Test Kits Recalled Due to Temperature Exposure

    McKesson Medical-Surgical is recalling multiple brands of drugs of abuse test kits because temperature excursions prior to delivery may have reduced product effectiveness.

    Product
    Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1596-2022·2022-08-31

    FDA Recalls Heparin Sodium Prefilled Syringes Due to Heat Damage

    Mckesson Medical-Surgical Inc. is recalling Excelsior Heparin Sodium prefilled syringes that may have been damaged by temperature excursions during manufacturing, potentially affecting their effectiveness. The recall covers lots received between June and September 2021.

    Product
    Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1611-2022·2022-08-31

    IV Securement Kit Recall Due to Storage Temperature Damage

    McKesson is recalling Medline Centurion IV Securement Kits that were exposed to high temperatures during storage, which may have impacted product effectiveness. No illnesses have been reported.

    Product
    MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1612-2022·2022-08-31

    Fischer Cone Biopsy Excisor recalled for potential temperature damage

    McKesson is recalling Fischer Cone Biopsy Excisor Model 900-157 units because temperature excursions during storage may have compromised product effectiveness.

    Product
    Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1619-2022·2022-08-31

    McKesson Medefil Normal Saline IV Flush Syringes Recalled for Temperature Exposure

    McKesson is recalling Medefil Normal Saline IV Flush Syringes (Models MIS-1130 and 191-MIS-1130) due to facility temperature excursions between June and August 2021. Products received through September 30, 2021 may have impaired effectiveness from temperature exposure prior to delivery.

    Product
    a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1624-2022·2022-08-31

    Fisher Scientific Sure-Vue Pipette Recall Due to Temperature Exposure

    Mckesson Medical-Surgical is recalling Fisher Scientific Sure-Vue RPR Dispensing Pipettes due to temperature excursions during storage from June to August 2021. Exposure to higher temperatures may have impacted product effectiveness.

    Product
    FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2022·2022-08-31

    McKesson and Metrex Research Glutaraldehyde Disinfectants Recalled Due to Temperature Excursion

    McKesson and Metrex Research are recalling glutaraldehyde disinfectants due to facility temperature excursions from June to August 2021 that may have reduced product effectiveness. Affected lots were distributed nationwide between June 1 and September 30, 2021.

    Product
    a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5%…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1569-2022·2022-08-31

    Anatomical Model Recalled for Wrong Product Shipped in Packaging

    Materialise USA LLC is recalling ProPlan CMF Anatomical Model units where packages labeled MU22-INA-DUQ contained the wrong anatomical model inside. Recipients should verify their package contents match the label.

    Product
    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1634-2022·2022-08-31

    Dynarex Lemon Glycerin Swabs recalled due to temperature exposure

    Dynarex lemon glycerin swabs distributed nationwide may have reduced effectiveness due to temperature excursions prior to delivery. All lots received between June 1 and September 30, 2021 are affected.

    Product
    Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1567-2022·2022-08-31

    Stryker SWANSON Finger Joint Implant Incorrect Sizing Label on Carton

    Wright Medical Technology is recalling 17 Stryker SWANSON Finger Joint Implants (size 00) due to incorrect sizing labels applied to carton packaging. Devices with lot numbers 1728375 and 1728376 were distributed across multiple US states and internationally.

    Product
    Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1635-2022·2022-08-31

    Dynarex DynaLube Lubricating Jelly Recalled Due to Temperature Excursions

    Mckesson is recalling Dynarex DynaLube lubricating jelly due to facility temperature excursions from June-August 2021 that may have degraded product effectiveness. Recall affects 17.5 boxes distributed nationwide between June-September 2021.

    Product
    DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2022·2022-08-31

    SteriSpine PS surgical screws recalled for patient label mislabeling

    FDA recalls 8 SteriSpine PS multi-axial fenestrated screw kits distributed in Maryland due to incorrect labeling on patient documentation. The patient labels list the wrong screw type, though other labeling and the devices themselves are correct.

    Product
    SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
    Category
    Medical Device
    Distribution
    1 state