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.

10951–10975 of 21617

  • ModerateFDA (Devices)·Z-1033-2018·2018-03-21

    Zimmer Biomet Recalls Natural-Knee II Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Natural-Knee II knee implants because LDPE packaging may leave residue on the polished implant surfaces.

    Product
    NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2018·2018-03-21

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Potassium Concentration Error

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate because some units in the affected lot had a potassium concentration of 2.25 mEq/L instead of the labeled 2.0 mEq/L.

    Product
    NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialy
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1061-2018·2018-03-21

    Zimmer Biomet Recalls Natural-Knee Flex Femoral Components Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Natural-Knee Flex femoral components because LDPE packaging may leave residue on the polished implant surface.

    Product
    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0941-2018·2018-03-21

    Howmedica Recalls Accolade and Restoration Hip Products Due to Sealing Defect

    Howmedica Osteonics Corp. is recalling 255 Accolade and Restoration hip products because the inner and outer sterile barriers were not fully sealed.

    Product
    Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1050-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surfaces.

    Product
    CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R CR-FLEX PCT FEM F-L CR-FLEX PCT FEM F-R CR-FLEX PCT FEM G-L CR-FLEX PCT FEM G-R This device is indicated for patients with seve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1021-2018·2018-03-21

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1064-2018·2018-03-21

    Zimmer Biomet Recalls Mislabeled Cannulated Screws Due to Labeling Error

    Zimmer Biomet is recalling six 6.5mm x 125mm x 16mm Cannulated Screws because they were mislabeled as 3.5mm x 24mm Cortical Locking screws.

    Product
    6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pe
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1044-2018·2018-03-21

    Zimmer Biomet Recalls LPS-FLEX Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 LPS-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1046-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surface.

    Product
    CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX OPT FEM F-L MINUS CR-FLEX OPT FEM F-R MINUS CR-FLEX OPT FEM G-L MINUS CR-FLEX OPT FEM G-R MINUS This device is indicated for patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0979-2018·2018-03-21

    Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching

    Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers. The size difference is visually recognizable to the user.

    Product
    Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2018·2018-03-21

    American Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sermorelin Acetate powder because stability data does not support the listed expiration dates.

    Product
    Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0994-2018·2018-03-21

    Arrow Central Venous Catheter Kits Recalled for Missing Identification Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1045-2018·2018-03-21

    Zimmer Biomet Recalls NEXGEN LPS-FLEX Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling NEXGEN LPS-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0973-2018·2018-03-21

    Laerdal LCSU 4 Suction Units Refused Importation for Lack of FDA Approval

    Laerdal Medical Corporation is recalling 204 LCSU 4 suction units that were refused entry into the U.S. by the FDA because they lacked necessary CDRH approvals.

    Product
    LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. High
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1024-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1059-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ D-R¿ CR-FLEX GSF PRECOAT SZ E-L¿ CR-FLEX GSF PRECOAT SZ E-R¿ CR-FLEX GSF PRECOAT SZ F-L¿ CR-FLEX GSF PRECOAT SZ F-R¿ CR-FLEX GSF PRECOAT SZ G-L¿ CR-FLEX GSK PRECOAT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2018·2018-03-21

    Hetero Labs Recalls Valacyclovir Tablets Due to Temperature Exposure

    Hetero Labs Limited is recalling Valacyclovir Tablets USP 1 gram because they were exposed to higher temperatures during transport. The recall covers 48,132 bottles distributed nationwide.

    Product
    VALACYCLOVIR — VALACYCLOVIR (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0921-2018·2018-03-21

    Ripple Chocolate Nutritious Pea Milk Recalled for High Coliform Levels

    Ripple Foods is recalling 448 cases of 48 oz. Chocolate Nutritious Pea Milk due to high levels of coliforms and Serratia liquefaciens.

    Product
    ripple Chocolate Nutritious Pea Milk; 48 oz. plastic bottle; 8 g Plant Based Protein 30% Less Sugar than Chocolate Milk; 50% More Calcium than Milk 32 mg DHA Omega 3's UPC: 8 55643 00607 6 Distributed by Ripple Foods, Emeryville, CA
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1049-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX PCT FEM F-L MINUS CR-FLEX PCT FEM F-R MINUS CR-FLEX PCT FEM G-L MINUS CR-FLEX PCT FEM G-R MINUS This device is indicated for patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1005-2018·2018-03-21

    Arrow CVC Kit Recall for Missing Lot and UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple i
    Category
    Medical Device
    Distribution
    7 states