The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

15976–16000 of 21645

  • ModerateFDA (Devices)·Z-2221-2015·2015-08-05

    EXP recalls 12mm Dilating Tip Trocars due to registration violations

    EXP Pharmaceutical Services Corp is recalling 12mm Dilating Tip Trocars because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2220-2015·2015-08-05

    EXP recalls 12 unregistered sterile dilating tip trocars

    EXP Pharmaceutical Services Corp is recalling 12 sterile dilating tip trocars because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2898-2015·2015-08-05

    Dairy Farmers of America Recalls Imitation Cheese Slices Due to Plastic Film

    Dairy Farmers of America is recalling specific Borden Sucrem and Country Fare imitation cheese slices because plastic film may remain attached to the product.

    Product
    Imitation Pasteurized Process Cheese Food: BORDEN SUCREM 12/16.4OZ SANDWICH SLICES, AMER IMIT, 451101550735. COUNTRY FARE 12/10.67OZ AMERICAN SANDWICH SLICES, IMIT SINGLE, 7545089000
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2231-2015·2015-08-05

    EXP Recalls Unregistered Stryker Femoral Canal Tips

    EXP Pharmaceutical Services Corp is recalling 12 Stryker Femoral Canal Tips because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2284-2015·2015-08-05

    Anspach Fluted Acorn Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 227 Fluted Acorn dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2243-2015·2015-08-05

    EXP Recalls PhysioMesh Surgical Mesh Due to Registration Violations

    EXP Pharmaceutical Services Corp is recalling PhysioMesh surgical mesh because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1515Q; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2228-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Specimen Retriever Bags Due to Registration Issues

    EXP Pharmaceutical Services Corp is recalling two units of specimen retriever bags because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2249-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Airway Stent Systems

    EXP Pharmaceutical Services Corp is recalling 10x40 Airway Stent Systems because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2246-2015·2015-08-05

    EXP Recalls 3.5mm Threaded Cerclage Pins Due to Registration Failures

    EXP Pharmaceutical Services Corp is recalling 3.5mm Threaded Cerclage Pins because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 298.838S; EXP (repackager), Synthes (OEM) Cerclage, fixation
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2871-2015·2015-08-05

    Dairy Farmers of America Recalls Fat Free American Cheese for Plastic Film

    Dairy Farmers of America is recalling various brands of fat free American cheese because a piece of plastic film strip might remain attached to the cheese slice.

    Product
    Fat Free Pasteurized Prepared Cheese Product: SOUTHHOME 12/12OZ AMERICAN FAT FREE YELLOW, 0788001319. ROUNDYS 12/12OZ AMER FAT FREE YLW, 1115051105. SHUR FINE 12/12OZ AMER FAT FREE YLW, 1116146131. HAGGEN 12/12OZ AMER FAT FREE YLW, 269845607.5 FOODDCLUB 12/12OZ AMER FAT…
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-1282-2015·2015-08-05

    Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

    Mutual Pharmaceutical is recalling 20,892 bottles of Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2224-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Auto Suture Endo Universal Devices

    EXP Pharmaceutical Services Corp is recalling three Auto Suture Endo Universal devices because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2875-2015·2015-08-05

    Dairy Farmers of America Recalls Borden Sensations Applewood Bacon Cheddar

    Dairy Farmers of America is recalling Borden Sensations Applewood Bacon Cheddar because a piece of plastic film might remain attached to the cheese slice.

    Product
    FLAVORED PASTEURIZED PREPARED CHEESE PRODUCT BORDEN SENSATIONS 12/8OZ APPLEWOOD BACON CHEDDAR 5300000980
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-1280-2015·2015-08-05

    Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

    Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2275-2015·2015-08-05

    Hardy Diagnostics Recalls MDR Acinetobacter and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling MDR Acinetobacter and other diagnostic media because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2904-2015·2015-08-05

    Dairy Farmers of America Recalls Fat Free Pepper Jack Cheese

    Dairy Farmers of America is recalling fat free pepper jack cheese products because a piece of plastic film strip might remain attached to the cheese slice.

    Product
    Fat Free Pasteurized Prepared Cheese Product: BORDEN 12/12OZ FF PEPPER JACK WHT, 5300000680..
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2241-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Stryker Round Fluted Bur Devices

    EXP Pharmaceutical Services Corp is recalling six Stryker Round Fluted Bur devices due to the company's failure to register as a medical device establishment.

    Product
    Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2891-2015·2015-08-05

    Dairy Farmers of America Recalls Pepper Jack Cheese Due to Plastic Film

    Dairy Farmers of America is recalling Sensations Southwest Pepper Jack cheese because plastic film strips may remain attached to the slices.

    Product
    Pasteurized Prepared Cheese Product: SENSATIONS 12/8OZ SOUTHWEST PEPPER JACK WHT, 5300000990.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2293-2015·2015-08-05

    Anspach 3mm Fluted Ball Dissection Tools Recalled for Labeling Inconsistency

    The Anspach Effort, Inc. is recalling 178 units of 3mm Fluted Ball dissection tools because the specified shaft exposure may be inconsistent with the product labeling.

    Product
    ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2213-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Sterile Laparoscope Pouches

    EXP Pharmaceutical Services Corp is recalling seven sterile laparoscope pouches because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2233-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders

    EXP Pharmaceutical Services Corp is recalling 10MM Vascular Transcatheter Septal Occluders because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2872-2015·2015-08-05

    Dairy Farmers of America Recalls Imitation Cheese Due to Plastic Film

    Dairy Farmers of America is recalling specific imitation cheese products because a piece of plastic film might remain attached to the cheese slice.

    Product
    Imitation Pasteurized Process Cheese Food: SANDWICH MATE 24/6.56OZ IMITATION WHITE, 7103026288. VALU TIME 12/10.67 OZ AMER IMITATION WHITE, 1122509215. SANDWICH MATE 12/8OZ AMER IMITATION PASTEURIZED PROCCESS.99 WHITE, 7103025055.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2217-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered GIA Auto Suture Loading Units

    EXP Pharmaceutical Services Corp is recalling GIA Auto Suture Loading Units because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2250-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Angio-Seal Vascular Closure Devices

    EXP Pharmaceutical Services Corp is recalling three Angio-Seal VIP Platform vascular closure devices due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular
    Category
    Medical Device
    Distribution
    6 states