Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

576–600 of 2738

LowFDA (Drugs)·D-0856-2020·2020-03-04
Golden State Medical Supply Recalls Tramadol Tablets Due to Labeling Error
Golden State Medical Supply is recalling Tramadol Hydrochloride 50 mg tablets because the patient leaflets contain incorrect dosing instructions for unscored tablets.
Product
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0860-2020·2020-03-04
Akorn Recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment Due to Particulate Matter
Akorn, Inc. is recalling specific tubes of Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper.
Product
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1354-2020·2020-03-04
Theralase TLC-2000 Laser System Recalled for Low Power Output
Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 905 nm laser diodes may be below rated power output.
Product
TLC-2000 Therapeutic Medical Laser System
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1348-2020·2020-03-04
Theralase TLC-2000 Laser Power Pack Recalled for Battery Testing Deficiency
Theralase Inc. is recalling 202 TLC-2000 Therapeutic Medical Laser System Power Packs because the internal battery pack was not tested to IEC-60601-1-2 standards.
Product
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0861-2020·2020-03-04
CVS Health Sodium Chloride Ophthalmic Ointment Recalled for Particulate Matter
Akorn, Inc. is recalling CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper inside the tubes.
Product
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1259-2020·2020-02-26
Advanced Bionics Cochlear Implant Electrode Recalled for Documentation Error
Advanced Bionics is recalling four HiResolution Bionic Ear System electrodes in Japan because three materials were omitted from the approved bio-compatibility list.
Product
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1252-2020·2020-02-26
Arrow Epidural Needle Kit Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling 180 units of the Arrow EPIDURAL NEEDLE KIT SL-05500 because the product lidstock contains the incorrect expiration date.
Product
Arrow EPIDURAL NEEDLE KIT SL-05500
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1266-2020·2020-02-26
Theralase TLC-2000 Laser System Recalled for Electromagnetic Interference Issues
Theralase Inc. is recalling 18 TLC-2000 Therapeutic Medical Laser Systems because the laser probes emit electromagnetic interference exceeding safety standards.
Product
TLC-2000 Therapeutic Medical Laser System
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0851-2020·2020-02-26
Teva Recalls Tramadol Tablets Due to Incorrect Package Insert Labeling
Teva Pharmaceuticals is recalling Tramadol Hydrochloride 50 mg tablets because the patient leaflets contain incorrect dosing instructions for unscored tablets.
Product
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1326-2020·2020-02-26
Theralase Inc. Recalls TLC-2000 Therapeutic Medical Laser Systems
Theralase Inc. is recalling 76 TLC-2000 laser systems because they were shipped with an incorrect power supply model.
Product
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1236-2020·2020-02-26
Arrow FlexTip Plus Epidural Catheterization Kit Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 250 units of the Arrow FlexTip Plus Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.
Product
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1255-2020·2020-02-26
Arrow PICC Kit Recalled for Incorrect Expiration Date on Lidstock
Arrow International is recalling specific lots of PICC kits because the lidstock displays the wrong expiration date.
Product
Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0844-2020·2020-02-26
Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failure
The Harvard Drug Group is recalling 246 cartons of Memantine Hydrochloride Extended-Release Capsules, 28mg, due to failed dissolution specifications observed during stability studies.
Product
MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1237-2020·2020-02-26
Arrow FlexTip Plus Epidural Catheterization Kit Recalled for Incorrect Expiration Date
Arrow International Inc is recalling Arrow FlexTip Plus Epidural Catheterization Kits because the product lidstock contains the incorrect expiration date.
Product
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1239-2020·2020-02-26
Arrow FlexTip Plus Catheterization Kit Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling 1,150 units of FlexTip Plus Combined Spinal Epidural Catheterization Kits because the product lidstock contains the incorrect expiration date.
Product
Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1244-2020·2020-02-26
Arrow Epidural Needle Component Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 1,839 units of Arrow Epidural Needle Component AN-05505 because the product lidstock contains the incorrect expiration date.
Product
Arrow EPIDURAL NEEDLE COMPONENT AN-05505
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1241-2020·2020-02-26
Arrow StimuCath Continuous Nerve Block Kit Recalled for Incorrect Expiration Date
Arrow International Inc is recalling 155 units of the StimuCath Continuous Nerve Block Kit because the product lidstock contains an incorrect expiration date.
Product
Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1119-2020·2020-02-19
LivaNova Sorin Connect Datapad Recall for Incorrect Manufacturing Date Labels
LivaNova USA Inc. is recalling five Sorin Connect Datapad devices because they have incorrect manufacturing date labels. The devices were distributed in New Jersey and California.
Product
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1229-2020·2020-02-19
Taewoong Esophageal Stents Recalled Due to Misprinted Instructions for Use
Taewoong Medical Co., Ltd. is recalling 178 esophageal stents because the Instructions for Use (IFUs) shipped with the devices were misprinted.
Product
Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F…
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-0843-2020·2020-02-19
Par Pharmaceutical Recalls Frovatriptan Tablets Due to Incorrect Expiration Date
Par Pharmaceutical is recalling 9,936 cartons of Frovatriptan Succinate Tablets, 2.5mg, because they are labeled with an incorrect expiration date.
Product
Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1100-2020·2020-02-12
Randox Liquid Clinical Chemistry Control Recalled for Transcription Error
Randox Laboratories is recalling Liquid Clinical Chemistry Control lot 1021 UE due to a transcription error in the Lipase value.
Product
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Category
Medical Device
Distribution
2 states
LowFDA (Drugs)·D-0829-2020·2020-02-12
Unichem Recalls Clonidine Hydrochloride Tablets Due to Benzophenone Migration
Unichem Pharmaceuticals is recalling Clonidine Hydrochloride tablets due to potential benzophenone migration from container labels. This is a precautionary measure.
Product
CLONIDINE HYDROCHLORIDE — CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0924-2020·2020-02-12
Neodent Tapered Guided Surgery Drill Recalled for Incorrect Laser Engraving
Jjgc Industria E Comercio De Materials Dentarios Sa is recalling two Neodent Tapered Guided Surgery Drills because the laser engraving incorrectly identifies the model.
Product
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-0876-2020·2020-02-05
GE Healthcare Recalls SIGNA Pioneer MRI Systems Due to Date Errors
GE Healthcare is recalling 62 SIGNA Pioneer MRI systems because an installation issue may cause incorrect dates on medical images.
Product
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0820-2020·2020-01-29
Koios DS Breast Software Recalled for Missing Quality Documentation
Koios Medical is recalling 10 units of Koios DS Breast software due to insufficient documentation of required quality procedures.
Product
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Category
Medical Device
Distribution
3 states