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.

17876–17900 of 21645

  • ModerateFDA (Devices)·Z-2582-2014·2014-09-10

    Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings due to a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

    Product
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1572-2014·2014-09-10

    Qualitest Recalls Oxycodone and Acetaminophen Tablets Due to Broken Tablets

    Qualitest Pharmaceuticals is recalling 23,544 bottles of Oxycodone and Acetaminophen tablets because broken tablets were found in sealed bottles.

    Product
    OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2571-2014·2014-09-10

    Siemens Recalls V5Ms Transesophageal Ultrasound Transducers Due to Material Deterioration

    Siemens is recalling 321 V5Ms transesophageal ultrasound transducers because the material covering the articulating section has deteriorated.

    Product
    V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2592-2014·2014-09-10

    MedComp Recalls Split Cath III Trays Due to Incorrect Length Labeling

    Medical Components, Inc. is recalling 110 Split Cath III Trays because they were incorrectly labeled as 32CM instead of 28CM.

    Product
    Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2585-2014·2014-09-10

    Zimmer Recalls Natural-Knee System Patella Bushings Due to Corrosion

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings because of a trend of complaints indicating product corrosion.

    Product
    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateUSDA FSIS·056-2014·2014-09-06

    Perdue Recalls Raw Chicken Due to Temperature Processing Deviation

    Perdue Foods is recalling approximately 720 pounds of raw, fresh whole young chickens due to a temperature processing deviation. No adverse reactions have been reported.

    Product
    Perdue Foods, LLC — Maryland Firm Recalls Fresh, Raw Chicken Products Due To Possible Processing Flaw
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1558-2014·2014-09-03

    Perrigo Recalls CareOne Nicotine Lozenges for Dissolution Failures

    Perrigo Holland Inc is recalling CareOne Nicotine Polacrilex Lozenges because they failed dissolution tests and contained broken lozenges.

    Product
    CAREONE NICOTINE — CAREONE NICOTINE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2543-2014·2014-09-03

    Zimmer Persona Distal Valgus Alignment Guide Recalled for Mechanical Defect

    Zimmer, Inc. is recalling 2,248 units of the Persona Distal Valgus Alignment Guide because the collet locks are seizing in the unlocked position.

    Product
    Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2542-2014·2014-09-03

    BD Vacutainer CPT Cell Preparation Tubes Recalled for Poor Separation

    Becton Dickinson is recalling specific lots of BD Vacutainer CPT Cell Preparation Tubes due to poor separation that reduces the number of recovered mononuclear cells.

    Product
    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2555-2014·2014-09-03

    Thermedx Fluid Management System Recalled for Canister Ring Manufacturing Change

    Thermedx LLC is recalling 21 units of the P4000 Fluid Management System because a manufacturing change to the canister ring may cause the deficit display to read higher than the actual fluid deficit.

    Product
    The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2558-2014·2014-09-03

    Civco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak

    Civco Medical Instruments is recalling 52 kits of CollectEVAC sterile devices because a pinhole leak in the packaging could compromise sterility.

    Product
    CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2549-2014·2014-09-03

    Zimmer Recalls Trauma Large Screws Due to Packaging Design Failures

    Zimmer, Inc. is recalling 972,125 units of sterile-packaged Trauma Large Screws because packaging design verification tests failed, resulting in compromised seal integrity.

    Product
    Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2552-2014·2014-09-03

    Zimmer Recalls Knee Stem Extensions Due to Packaging Design Failures

    Zimmer, Inc. is recalling specific knee stem extensions and impactor sleeves because packaging design verification tests failed, potentially compromising device sterility.

    Product
    Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2550-2014·2014-09-03

    Zimmer Recalls Trauma Tubes and Plates Due to Packaging Failures

    Zimmer, Inc. is recalling specific trauma tubes and plates because packaging design verification tests failed, resulting in compromised seal integrity.

    Product
    Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2548-2014·2014-09-03

    Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

    Product
    Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2398-2014·2014-09-03

    Beta Labs Recalls Oxyphen XR Fat Burner Due to Illegal DMAA Content

    Beta Labs is recalling Oxyphen XR fat burner capsules because they contain DMAA, a substance not permitted in dietary supplements.

    Product
    Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599747
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2546-2014·2014-09-03

    Zimmer Recalls Knee Instrument Fixation Screws Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of knee fixation screws worldwide because packaging design verification tests failed, potentially compromising sterility.

    Product
    Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2547-2014·2014-09-03

    Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

    Product
    Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2329-2014·2014-08-27

    Jody's Funfetti Recalled for Undeclared Food Dyes

    Jody's Inc. is recalling Funfetti candy due to undeclared food dyes Blue #1, Red #3, and Yellow #5.

    Product
    Jody's, Funfetti, Net Wt 7.5 oz (213 g) and 4 oz in clear cellophane bag.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2250-2014·2014-08-27

    Zimmer Recalls 4.5 mm Malleolar Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws because they failed a leak test due to inner cavity damage.

    Product
    4.5 mm Malleolar Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2266-2014·2014-08-27

    Vascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling

    Vascutek is recalling Gelweave Vascular Prostheses because the included cautery has a shorter shelf life than the graft, creating a labeling discrepancy.

    Product
    Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2271-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2283-2014·2014-08-27

    AMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5 Product Usage: AMO TECNIS CL monofocal foldable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2276-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 14.5, 15.0 Product Usage: AMO TECNIS CL monofocal foldable…
    Category
    Medical Device
    Distribution
    Distributed nationwide