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.

20351–20375 of 21633

  • ModerateFDA (Devices)·Z-1387-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 78 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1395-2013·2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage Risk

    Stryker Orthobiologics is recalling five Aliquot Reamer units because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1409-2013·2013-06-05

    Spinal Solutions Recalls 45 mm Screws Due to Missing Instructions

    Spinal Solutions is recalling 24 units of 45 mm screws because directions for use and surgical techniques were not provided to every physician.

    Product
    45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-500-2013·2013-06-05

    Mylan Recalls Mislabelled Ropinirole Hydrochloride Tablets Due to Strength Error

    Mylan Pharmaceuticals is recalling 3,048 bottles of Ropinirole hydrochloride tablets because 3 mg bottles were incorrectly labeled as 4 mg.

    Product
    Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1410-2013·2013-06-05

    Spinal Solutions Recalls 50 mm Screws Due to Missing Surgical Instructions

    Spinal Solutions is recalling 52 units of 50 mm screws because directions for use and surgical techniques were not provided to every physician.

    Product
    50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1415-2013·2013-06-05

    Spinal Solutions Recalls Loaner Bins and Sterilization Trays for Missing Instructions

    Spinal Solutions, LLC is recalling 56 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2013·2013-06-05

    Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions

    Spinal Solutions is recalling loaner bins and sterilization trays for spinal implants because directions for use and surgical techniques were not provided to every physician.

    Product
    Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1389-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 411 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1427-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Cannulas for Labeling Clarification

    Intuitive Surgical is recalling 8mm cannulas to clarify existing labeling information and operating procedures.

    Product
    Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2013·2013-06-05

    Becton Dickinson Recalls BBL DrySlide PYR Kits Due to Packaging Error

    Becton Dickinson is recalling 610 BBL DrySlide PYR Kits because they were placed in incorrect packaging for distribution to laboratories.

    Product
    BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling 50 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.

    Product
    Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1388-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 164 units of the Aliquot Plunger Delivery System because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1401-2013·2013-06-05

    Alere hCG Combo Cassette Kits Recalled for Incorrect Packaging Inserts

    Alere San Diego, Inc. is recalling 3,975 hCG Combo Cassette kits because some were packaged with the wrong product insert.

    Product
    Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1424-2013·2013-06-05

    Intuitive Surgical Recalls da Vinci TORS User Manual Addendum

    Intuitive Surgical is recalling 1,374 user manual addenda for the da Vinci Surgical System to remove an indication and amend warnings for Transoral Surgery.

    Product
    User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-496-2013·2013-06-05

    Teva Recalls Seasonale Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Seasonale tablets because testing detected an impurity called N-Butyl-Benzene Sulfonamide.

    Product
    Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1399-2013·2013-06-05

    Stryker Orthobiologics Aliquot Catheter Recall for Use Error

    Stryker Orthobiologics is recalling 69 Aliquot Catheters due to reported breakage during vertebroplasty procedures attributed to use errors.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1378-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants

    Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.

    Product
    Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2013·2013-06-05

    Intel-GE Care Innovations Recalls QuietCare-Networked Monitoring Devices

    Intel-GE Care Innovations is recalling 46 QuietCare-Networked devices due to duplicate alerts. The devices are used to monitor senior housing residents.

    Product
    QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1379-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants

    Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants and instruments because directions for use and surgical techniques were not provided to every physician for every surgery.

    Product
    Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays

    Orthopedic Alliance LLC is recalling 57 units of loaner bins and sterilization trays because surgical instructions were not provided to every physician.

    Product
    UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-499-2013·2013-06-05

    Physicians Total Care Recalls Camila Tablets Due to Impurity

    Physicians Total Care is recalling specific lots of Camila 0.35 mg tablets because testing detected an impurity called N-Butyl-Benzene Sulfonamide.

    Product
    Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1425-2013·2013-06-05

    Intuitive Surgical Recalls Tip Cover Accessories for Labeling Clarification

    Intuitive Surgical is recalling 50,000 boxes of Tip Cover Accessories for the da Vinci Surgical System to clarify existing labeling and related cautions.

    Product
    Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1392-2013·2013-06-05

    Stryker Orthobiologics Aliquot Catheter Recall for Use Error Revision

    Stryker Orthobiologics is recalling 27 Aliquot Catheters to revise instructions after reported breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2013·2013-06-05

    Stryker Orthobiologics Aliquot Diamond Needle Recall for Catheter Breakage

    Stryker Orthobiologics is recalling 19 units of the Aliquot Diamond Needle due to reported catheter breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2013·2013-06-05

    Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 35 units of the Aliquot Beveled Needle because the catheter may break during removal. The issue is attributed to user error, and the correction involves updating the Directions for Use.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide