September 2020 recalls

631 recalls were announced in September 2020.

What the numbers show

Critical: 56
Severe: 123
High: 285
Moderate: 154
Low: 13

Of the 631 recalls this month scored against our rubric, 9% are Critical, 19% are Severe.

Which agencies issued them

601–631 of 631

HighFDA (Food)·F-1301-2020·2020-09-02
Wegmans Recalls Fresh Cooked Shrimp Due to Listeria Contamination
Wegmans Food Markets is recalling fresh cooked shrimp products potentially contaminated with Listeria monocytogenes. The recall affects packages sold in six states between August 5 and 7, 2020.
Product
Fresh Cooked Shrimp; 6ct, 12ct, 20ct, 60ct, 80ct; shrimp cocktail with lemon and cocktail sauce; packaged on plastic trays; package size varies; keep refrigerated
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-2848-2020·2020-09-02
Siemens Cios Alpha and Spin Mobile X-Ray Systems Recalled for Electrical Malfunction
Siemens is recalling Cios Alpha and Cios Spin mobile X-ray systems because a hardware error could cause permanent loss of imaging functionality.
Product
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2849-2020·2020-09-02
Conformis iTotal Knee Implant Kit Recalled for Incorrect Contents
Conformis, Inc. is recalling one iTotal CR Knee Replacement kit because the box contained implants and jigs for a different serial number.
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Category
Medical Device
Distribution
1 state
ModerateFDA (Drugs)·D-1545-2020·2020-09-02
Hetero Labs Recalls Losartan Potassium Tablets Due to Bulging Complaints
Hetero Labs is recalling 43,512 bottles of Losartan Potassium 50 mg tablets due to a complaint of bulging tablets.
Product
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-2889-2020·2020-09-02
BD SafetyGlide Syringes Recalled for Incorrectly Printed Scale Markings
Becton Dickinson is recalling 3mL SafetyGlide syringes because the printed scale markings are skewed, missing, or partially printed.
Product
BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2901-2020·2020-09-02
Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect
Neurovision Medical Products Inc. is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.
Product
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an ope
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2900-2020·2020-09-02
Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect
Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.
Product
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2904-2020·2020-09-02
Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening
Neurovision Medical Products Inc. is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften, potentially damaging the device and stopping signal transmission.
Product
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1548-2020·2020-09-02
FDA Recalls Hand Sanitizer Gel Due to Manufacturing Deviations
Resource Recovery & Trading LLC is voluntarily recalling 17,280 bottles of hand sanitizer gel due to cGMP deviations. The product was distributed in Alabama and Georgia.
Product
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-2874-2020·2020-09-02
Ortho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides because the drug etrombopag interferes with the test results.
Product
VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1259-2020·2020-09-02
UNFI Recalls Temperature-Abused Eggs from Multiple Brands
UNFI General Corporate is recalling 226 cases of eggs from multiple brands due to temperature abuse. The products were distributed in Illinois, Indiana, Missouri, and Wisconsin.
Product
The following products received from the UNFI Distribution Center Champaign, IL on 7/12/2020: Ditch Farms Eggs brand: Grade A Large (20/18ct; UPC 2009194510035) and (30/12ct; UPC 1004127044750) and (30/6ct; UPC 1009194510032) ; Grade A Large Brown (30/12ct; UPC 2009194510060)
Category
Food
Distribution
4 states
ModerateFDA (Drugs)·D-1540-2020·2020-09-02
Rocky Mountain Sunscreen Lip Balm Recalled for Excess Octisalate
Yusef Manufacturing is recalling Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm because the active ingredient Octisalate was found at 15% above the label claim.
Product
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1539-2020·2020-09-02
Ecolab Recalls Hand Sanitizer Due to Discoloration and Foreign Substance
Ecolab Inc is recalling 305 drums of 55-gallon hand sanitizer nationwide due to discoloration and the presence of a foreign substance.
Product
Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1352-2020·2020-09-02
Sun Valley Foods Recalls Diced Green Chilies for Foreign Material
Sun Valley Foods LLC is recalling 324 drums of diced green chilies due to the potential to contain foreign material.
Product
Material Number 7002 Unique Tracking Number 1000035843 3/8" Diced Green Chilies (440 lb drum)
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-2902-2020·2020-09-02
Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Softening
Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially damaging the device and stopping EMG signal transmission.
Product
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2885-2020·2020-09-02
Canon Medical Ultimax-i Imager Processor Recalled for Image Transfer Errors
Canon Medical System is recalling 11 Ultimax-i Imager Processors because images transferred to archival systems may not match the number originally acquired.
Product
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-2898-2020·2020-09-02
Siemens E.cam and Symbia Systems Recalled for Detector Time Loss
Siemens Medical Solutions is recalling E.cam and Symbia systems with foresight detectors because they may lose detector time information during gated or dynamic acquisitions.
Product
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1258-2020·2020-09-02
O Organics Tahini Recalled Due to Loose Metal Lids
ACME Food Sales Inc. is recalling O Organics Tahini because some glass jars have loose-fitting metal lids that are not secured tightly.
Product
O Organics Tahini is 100% organic ground slightly roasted sesame seed paste, packaged in 16oz glass jar with metal screw on/off lid and has a paper anti tampering seal connecting the lid with the jar. UPC 0 79893 39024 6. The label is read in parts: "***O Organic TAHINI *** IN
Category
Food
Distribution
7 states
ModerateFDA (Devices)·Z-2899-2020·2020-09-02
RayCare Oncology Software Recalled for Offline Image Review Error
RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.
Product
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2875-2020·2020-09-02
Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.
Product
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1533-2020·2020-09-02
Hikma Recalls Buprenorphine Hydrochloride Injection Due to Low Potency
Hikma Pharmaceuticals is recalling 97,890 vials of Buprenorphine Hydrochloride Injection because stability testing revealed the drug was sub-potent.
Product
BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1306-2020·2020-09-02
Wegmans Recalls Soft Shell Crab Tempura Due to Listeria Risk
Wegmans is recalling soft shell crab tempura products potentially contaminated with Listeria monocytogenes. Consumers should check their refrigerators and discard or return the product.
Product
Crab Soft Shell Tempura; Individual; Wegmans ready to cook prime soft-shell crab tempura; packaged in an oven ready tray; package size varies; keep refrigerated
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-2905-2020·2020-09-02
Neurovision Cobra EMG Endotracheal Tubes Recalled for Insulation Softening
Neurovision is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.
Product
Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2886-2020·2020-09-02
Match Point System surgical instrument recalled due to incorrect procedure side labeling
The Match Point System surgical instrument was recalled because the procedure side on planning reports was incorrectly marked as 'Left' instead of 'Right' for right-side procedures.
Product
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2877-2020·2020-09-02
OraSure Benzodiazepine Micro-Plate Recalled for Incorrect Lot Number Labeling
OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.
Product
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1541-2020·2020-09-02
Red Cross Oral Pain Relief Recalled for Cotton Pellet Labeling Error
The Mentholatum Company is recalling Red Cross Oral Pain Relief blister packs because the included cotton pellet box incorrectly lists Natural Eugenol Oil as an ingredient.
Product
RED CROSS ORAL PAIN RELIEF — RED CROSS ORAL PAIN RELIEF (BENZOCAINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2876-2020·2020-09-02
OraSure Benzodiazepine Micro-Plate Recall Due to Incorrect Lot Number Labeling
OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.
Product
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·20V528000·2020-09-01
2020-2021 BMW X5, X6, X7 Headlamp Non-Compliance Recall
BMW is recalling certain 2020-2021 X5, X6, and X7 models because their headlamps may emit unintended blue light, which could confuse oncoming drivers and increase crash risk. Dealers will replace affected headlamps at no cost.
Product
BMW — BMW X6, X5, X7
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·20V529000·2020-09-01
Daimler Trucks Recalls Freightliner Chassis Due to Tire Valve Stem Risk
Daimler Trucks is recalling certain Freightliner chassis because a tire valve stem extension may contact the wheel rim, potentially causing a loss of tire pressure and increasing crash risk.
Product
FCCC — FCCC XCS, XCM, XCR, MC
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·20V527000·2020-09-01
Engine harness defect may cause stalling in 2018–2021 Freightliner trucks
Engine harness wires may chafe and short in certain 2018–2021 Freightliner trucks, causing unexpected engine stalling that can increase crash risk.
Product
FREIGHTLINER — FREIGHTLINER 114SD, 108SD, BUSINESS CLASS M2
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·20E062000·2020-09-01
Harbor Freight Recalls Pittsburgh Automotive A/C Manifold Gauge Sets
Harbor Freight is recalling Pittsburgh Automotive A/C Manifold Gauge Sets due to swapped labels that may cause pressurized refrigerant release and injury.
Product
EQUIPMENT recall
Category
Consumer Product
Distribution
Distributed nationwide

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