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.

18651–18675 of 21645

  • ModerateFDA (Devices)·Z-1210-2014·2014-03-26

    DeRoyal Cotton Adjustable Limb Holders Recalled for Moldy Smell

    DeRoyal Industries is recalling 8,962 pairs of cotton adjustable limb holders due to a moldy smell. The products were distributed in the US and Argentina.

    Product
    DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1257-2014·2014-03-26

    Zimmer Recalls Natural-Knee II Tibial Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee II Posterior Stabilized Condylar Tibial Inserts because free radical oxidation caused discoloration.

    Product
    Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1260-2014·2014-03-26

    Zimmer Recalls Apollo Knee System Tibia Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Knee System tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.

    Product
    Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1261-2014·2014-03-26

    Zimmer Recalls Apollo Revision Knee System Tibia Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Revision/Constrained Knee System tibia inserts because they were discolored due to premature oxidation during storage.

    Product
    Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1243-2014·2014-03-26

    Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Labeling Error

    Biomet is recalling 10 Intramedullary Bone Saw Cam Assemblies because they were incorrectly labeled as Saw Blade Assemblies.

    Product
    Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1259-2014·2014-03-26

    Zimmer Recalls Apollo Knee Tibial Baseplates Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Knee Tibial Baseplates and Inserts because free radical oxidation caused discoloration in some units.

    Product
    Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1258-2014·2014-03-26

    Zimmer Recalls Apollo Knee System Patella Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of Apollo Knee System patella components due to discoloration caused by premature oxidation during storage.

    Product
    Apollo" Knee System: APOLLO PATELLA SZ0 28MM R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1247-2014·2014-03-26

    Stryker Recalls 2.5MM Aggressive Sinuscopic Shaver Blades Due to Missing Scale

    Stryker is voluntarily recalling 90 units of 2.5MM Aggressive Sinuscopic Shaver Blades because the etched line guide is missing the required 1cm to 7cm number scale.

    Product
    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures…
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-1172-2014·2014-03-26

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because out-of-specification results indicate the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2014·2014-03-26

    Zimmer Recalls Natural-Knee Flex System Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of the Natural-Knee Flex System due to discoloration caused by premature oxidation during storage.

    Product
    Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2014·2014-03-26

    Ortho-Clinical VITROS White Correction Factor Slides Recalled for Labeling Error

    Ortho-Clinical Diagnostics is recalling VITROS White Correction Factor Slides because an incorrect assay value was printed on the carton, which may delay reporting of specific test results.

    Product
    VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2014·2014-03-26

    Zimmer Recalls Natural-Knee Tibial Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee Congruent Tibial Inserts with Screws because a complaint identified discoloration caused by premature oxidation during storage.

    Product
    Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1206-2014·2014-03-19

    DePuy S-ROM Rotating Hinge Femoral Components Recalled for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femoral components due to potential holes in the sterile barrier pouches.

    Product
    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1192-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling G2001 Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use in-vitro diagnostic tools used for drawing arterial blood.

    Product
    G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of…
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Food)·F-1627-2014·2014-03-19

    F & S Produce Recalls Mislabeled Roasting Cinnamon Butternut Squash

    F & S Produce Co., Inc. is recalling Roasting Cinnamon Butternut Squash because the product is mislabeled. The recall covers 429 units distributed in California.

    Product
    Roasting Cinnamon Butternut Squash Net Wt. 2 lbs (907 g) Foam Tray with 3 per case. Keep Refrigerated Distributed by Renaissance Food Group LLC UPC 825786790333
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1183-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an…
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1184-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the…
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1178-2014·2014-03-19

    Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls

    Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.

    Product
    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-1626-2014·2014-03-19

    Sysco Blueberry Pie Filling Withdrawn Due to Metal Contact Risk

    Lyons Magnus is withdrawing Sysco Blueberry Pie Filling after inspection found metal on metal contact in production equipment. No metal has been found in the product.

    Product
    Classic Sysco Custom Ready to Use Blueberry Pie Filling; Artificial Flavor #10 can - Net wt 7 lbs 1 oz (2kg) UPC 1 00 74865 38258 5 Manufactured for Sysco by Lyons Magnus, Fresno, CA
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1179-2014·2014-03-19

    Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls Due to Concentration Drift

    Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.

    Product
    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1195-2014·2014-03-19

    Veridex Recalls CELLTRACKS Analyzer II Microscopes Due to Camera Failures

    Veridex, LLC is recalling 19 CELLTRACKS Analyzer II fluorescence microscopes because of reported camera failures. The devices are used for analyzing rare cells in biological fluids.

    Product
    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1154-2014·2014-03-19

    Clarity Medical Systems Recalls RetCam Devices Due to Age Calculation Error

    Clarity Medical Systems is recalling RetCam 3, Portable, and Shuttle devices because a software error causes incorrect patient age calculations.

    Product
    RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1156-2014·2014-03-19

    Mindray Recalls Panorama Central Station for Time Clock Data Lag

    Mindray is recalling 732 Panorama Central Stations because Full Disclosure data and event indicators may lag behind the system time clock.

    Product
    Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1625-2014·2014-03-19

    Lyons Magnus Recalls Cherry Pie Filling Due to Metal Contact Risk

    Lyons Magnus is withdrawing 500 cases of Classic Sysco Custom Ready to Use Cherry Pie Filling after an inspection found metal-on-metal contact on a production auger.

    Product
    Classic Sysco Custom Ready to Use Cherry Pie Filling; with other Natural Flavors #10 can - Net wt 7 lbs (3.18kg) UPC 1 00 74865 38257 8 Manufactured for Sysco by Lyons Magnus, Fresno, CA
    Category
    Food
    Distribution
    6 states