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.

10176–10200 of 21617

ModerateFDA (Devices)·Z-2610-2018·2018-08-15
ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific blood set accessories because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free wit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2623-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers devices distributed in the US and several international countries.
Product
84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture d
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1074-2018·2018-08-15
Teva Recalls Omega-3 Capsules Due to Unapproved Manufacturing Material
Teva Pharmaceuticals is recalling 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules because an API material used in manufacturing did not receive regulatory approval prior to release.
Product
Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-2614-2018·2018-08-15
ICU Medical Recalls Lopez Valve Devices Due to DEHP Labeling Error
ICU Medical is recalling Lopez Valve, Sterile blood tubing accessories because some units were incorrectly labeled as not containing DEHP, though they may contain small amounts.
Product
Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2650-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2617-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withd
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2638-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2632-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling blood tubing accessories labeled as DEHP-free because they may contain small amounts of DEHP.
Product
100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipunctu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2740-2018·2018-08-15
Beaver Visitec Recalls Mislabeled Ophthalmic Slit Knives
Beaver Visitec is recalling 440 ophthalmic slit knives due to mislabeling on individual packages within correctly labeled cartons.
Product
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2637-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2606-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 119-inch blood sets labeled as DEHP-free because they may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.
Product
119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2619-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2635-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 105-inch Y-Type Blood Sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2626-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, though they may contain small amounts.
Product
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2607-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood set units because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of b
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2656-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts of the chemical.
Product
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing set
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2577-2018·2018-08-15
Qiagen AmniSure ROM Test Recalled for Potential Control Line Failure
Qiagen Sciences is recalling 1,620 AmniSure ROM Test kits because the control line may not appear on the test strip, potentially affecting result validity.
Product
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1049-2018·2018-08-15
Longbow Eyewash Solution Recalled for CGMP Deviations
Longbow First Aid Products Manufactory is voluntarily recalling 14,400 bottles of Eyewash Purified water 98.3% Ophthalmic Solution due to CGMP deviations.
Product
Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-2652-2018·2018-08-15
ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling
ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1043-2018·2018-08-15
PharMEDium Recalls Fentanyl Citrate IV Bags Due to CGMP Deviations
PharMEDium Services is recalling specific lots of Fentanyl Citrate IV bags because they were released while a hood certification discrepancy was under investigation.
Product
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-2622-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2653-2018·2018-08-15
ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or ven
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1034-2018·2018-08-15
Baxter Recalls Levofloxacin Injection Due to High Potency Levels
Baxter Healthcare is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification potency results.
Product
LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2646-2018·2018-08-15
ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error
ICU Medical is recalling 160,016 units of blood tubing accessories because some were labeled as not containing DEHP, despite potentially containing small amounts.
Product
132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2611-2018·2018-08-15
ICU Medical Blood Set Recall for Incorrect DEHP Labeling
ICU Medical is recalling blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.
Product
32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free with
Category
Medical Device
Distribution
Distributed nationwide