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Recalls affecting U.S. Virgin Islands

Data last updated: September 8, 2026 at 1:13 PM UTC

15,933 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

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UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

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UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

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UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
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UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

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FDA has not published a risk classification for this recall yet.

Recall #:
83509
Lot/product code:
Lot Numbers: H938905 63630-A1769, H938905 63630-A1771, H938905 63630-A1773, H938905 63630-A2647, H938905 63630-A2649, H938905 63630-A2651, H938905 63630-A2655, H938905 63630-A2657, H938905 63630-A2659, H938905 63630-A2661, H938905 63630-A3950, H938905 63630-A3952, H938905 63630-A3954, H938905 63630-A3956, H938905 63630-A3957, H938905 63630-A3959, H938905 63630-A3961, H938905 63630-A3963, H938905 63630-A3965, H938905 63630-A3968, H938905 63630- A5338, H938905 63630-A5340, H938905 63630-A5342, H938905 63630-A5344, H938905 63630-A5346, H938905 63630-A5348, H938905 63630-A5350
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

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FDA has not published a risk classification for this recall yet.

Recall #:
83509
Lot/product code:
Lot Numbers: 66630-A2771, 66630-A4282
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83509
Lot/product code:
Lot Numbers: 66615-A3539, 66615-A5098
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 24, 2018

Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
81092
Lot/product code:
Model Number 453564669081;  System Serial Number (UDI): US1814000001 ((01)00884838091474(21)US1814000001), US1814000002 ((01)00884838091474(21)US1814000002), US1814000003 ((01)00884838091474(21)US1814000003), US1814000004 ((01)00884838091474(21)US1814000004), US1814000006 ((01)00884838091474(21)US1814000006), US1814000007 ((01)00884838091474(21)US1814000007), US1814000008 ((01)00884838091474(21)US1814000008), US1814000011 ((01)00884838091474(21)US1814000011), US1814000012 ((01)00884838091474(21)US1814000012), US1814000013 ((01)00884838091474(21)US1814000013), US1814000014 ((01)00884838091474(21)US1814000014), US1814000016 ((01)00884838091474(21)US1814000016), US1814000017 ((01)00884838091474(21)US1814000017), US1814000018 ((01)00884838091474(21)US1814000018), US1814000019 ((01)00884838091474(21)US1814000019), US1814000020 ((01)00884838091474(21)US1814000020), US1814000022 ((01)00884838091474(21)US1814000022), US1814000023 ((01)00884838091474(21)US1814000023), US1814000024 ((01)00884838091474(21)US1814000024), US1814000027 ((01)00884838091474(21)US1814000027), US1814000028 ((01)00884838091474(21)US1814000028), US1814000029 ((01)00884838091474(21)US1814000029), US1814000030 ((01)00884838091474(21)US1814000030), US1814000031 ((01)00884838091474(21)US1814000031), US1814000032 ((01)00884838091474(21)US1814000032), US1814000033 ((01)00884838091474(21)US1814000033), US1814000034 ((01)00884838091474(21)US1814000034), US1814000035 ((01)00884838091474(21)US1814000035), US1814000036 ((01)00884838091474(21)US1814000036), US1814000037 ((01)00884838091474(21)US1814000037), US1814000038 ((01)00884838091474(21)US1814000038), US1814000039 ((01)00884838091474(21)US1814000039), US1814000040 ((01)00884838091474(21)US1814000040), US1814000041 ((01)00884838091474(21)US1814000041), US1814000043 ((01)00884838091474(21)US1814000043), US1814000044 ((01)00884838091474(21)US1814000044), US1814000045 ((01)00884838091474(21)US1814000045), US1814000046 ((01)00884838091474(21)US1814000046), US1814000047 ((01)00884838091474(21)US1814000047), US1814000048 ((01)00884838091474(21)US1814000048), US1814000049 ((01)00884838091474(21)US1814000049), US1814000050 ((01)00884838091474(21)US1814000050), US1814000051 ((01)00884838091474(21)US1814000051), US1814000052 ((01)00884838091474(21)US1814000052), US1814000053 ((01)00884838091474(21)US1814000053), US1814000054 ((01)00884838091474(21)US1814000054), US1814000055 ((01)00884838091474(21)US1814000055), US1814000056 ((01)00884838091474(21)US1814000056), US1814000058 ((01)00884838091474(21)US1814000058), US1814000059 ((01)00884838091474(21)US1814000059), US1814000060 ((01)00884838091474(21)US1814000060), US1814000061 ((01)00884838091474(21)US1814000061), US1814000062 ((01)00884838091474(21)US1814000062), US1814000063 ((01)00884838091474(21)US1814000063), US1814000064 ((01)00884838091474(21)US1814000064), US1814000065 ((01)00884838091474(21)US1814000065), US1814000066 ((01)00884838091474(21)US1814000066), US1814000067 ((01)00884838091474(21)US1814000067), US1814000068 ((01)00884838091474(21)US1814000068), US1814000069 ((01)00884838091474(21)US1814000069), US1814000070 ((01)00884838091474(21)US1814000070), US1814000072 ((01)00884838091474(21)US1814000072), US1814000074 ((01)00884838091474(21)US1814000074), US1814000078 ((01)00884838091474(21)US1814000078), US1814000081 ((01)00884838091474(21)US1814000081), US1814000082 ((01)00884838091474(21)US1814000082), US1814000083 ((01)00884838091474(21)US1814000083), US1814000084 ((01)00884838091474(21)US1814000084), US1814000085 ((01)00884838091474(21)US1814000085), US1814000086 ((01)00884838091474(21)US1814000086), US1814000087 ((01)00884838091474(21)US1814000087), US1814000088 ((01)00884838091474(21)US1814000088), US1814000089 ((01)00884838091474(21)US1814000089), US1814000092 ((01)00884838091474(21)US1814000092),  US1814000094 ((01)00884838091474(21)US1814000094), US1814000096 ((01)00884838091474(21)US1814000096).
Recalling firm:
Invivo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
83820
Lot/product code:
Lot number 91401455
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.

The WHD/WHV impactors can rust over time due to an improper manufacturing process.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
83820
Lot/product code:
Lot numbers 049045, 049044, and 049044R1.
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83820
Lot/product code:
Lot numbers 91500604 and 91600017
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
83820
Lot/product code:
Lot number 2858, 2861, and 3749
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83820
Lot/product code:
Lot numbers 3168, 3464, 3660, 3963, and 4216.
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 2, 2018

Medtronic CareLink 2090 Programmer

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

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FDA has not published a risk classification for this recall yet.

Recall #:
81300
Lot/product code:
All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 2, 2018

Medtronic CareLink Encore 29901 Programmer

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

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FDA has not published a risk classification for this recall yet.

Recall #:
81300
Lot/product code:
All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 10, 2018

IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.

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FDA has not published a risk classification for this recall yet.

Recall #:
81531
Lot/product code:
All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 16, 2018

Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box

Potential that gauze pads may not be fully sterilized

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FDA has not published a risk classification for this recall yet.

Recall #:
81555
Lot/product code:
ASO Item No. 780655, Batch/Lot # 2384-20180524
Recalling firm:
ASO, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 17, 2018

Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.

There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.

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FDA has not published a risk classification for this recall yet.

Recall #:
81169
Lot/product code:
All lot numbers manufactured from October 30, 2006 to August 15, 2018, with affected Product and Lot Numbers distributed worldwide - Product Number (Lot Numbers):  825200641 (1271924, 1074548, 1186516, 1364805, 1262505, 1269165, 1313148, 1296901, 1330427, 1382941, 1321674, 1339578, 1265501, 1344236,  1261415, 1372437, 1353961, M054680, M118520, 1003492, 1058979, 1287750);   825200842 (1189516, 1074551, 1319855, 1298913, 1057370, M054700, M118540);   825201041 (1269824, 1277860, 1186520, 1195261, 1230705, 1340401, 1253661, 1263078, 1288520, 1186520 , 1227431, 1368550, 1376018, 1382289, 1316167, 1104163, 1074553, 1307329, 1296285, 1332473, 1319856, 1053400, 1337541, M054720, M118550);   825201241 (1185831, 1372500, 1364881, 1238365, 1273017, 1302457, 1298771, 1186521, 1269168, 1183846, 1323532, 1074555, 1316169, 1344797,  1333774, 1057371, 1361470, 1265502, 1289744, M054730, M118560);   825201441 (1185832, 1189518, 1339287, 1274102, 1281289, 1320136, 1314041, 1360269, 1328548, 1003493, 1074556, M054740, M112910);   825210830 (1264551, 1313443, 1338468, 1212278, 1262656, 1271357, 1320727);   825211030 (1271954, 1293167, 1287813, 1313444, 1265025, 1320728, 1212279, 1342362);   825211230 (1240940, 1253421, 1245260);   825211430 (1253422, 1240941);   825200841 (1274105, 1185829, 1281667, 1257138, 1368638, 1306948, 1265989, 1296284, 1298436, 1189515, 1269820, 1319630, 1376097, 1362251, 1323968, 1107980, 1333771, 1261416, 1378166, 1053398, 1338467, 1288856, 1074550, M054690, M118530, 1241165, 1243611, 1248730, 1253658, 1262506);   Affected Part and Lot numbers distributed Nationwide - Part Number (Lot Numbers):  82520.0641 (1058979, 1074548, 1339578, 1003492, 1313148, M054680, 1186516, 1271924, 1262505, 1269165, 1296901, 1364805, 1330427, 1344236,  M118520, 1287750, 1353961, 1382941);   82520.0841 (1074550, 1333771, 1323968, M054690, 1281667, 1274105, 1241165, 1053398, 1269820, 1243611, 1248730, 1262506, 1288856, 1298436, M118530, 1362251, 1185829, 1198515, 1338467, 1378166, 1253658, 1296284);   82520.0842 (M118540, M054700, 1189516, 1319855);   82520.1041 (1074553, 1319856, 1316167, 1277860, M054720, 1053400, 1269824, 1230705, 1253661, 1263078, 1376018, 1288520, 1332473, M118550, 1337541, 1186520, 1195261, 1382289);   82520.1241 (1074555, 1333774, 1302457, 1057371, M054730, 1269168, M118560, 1238365, 1186521, 1289744, 1372500, 1298771, 1344797, 1361470, 1265502, 1185831);   82520.1441 (1074556, 1320136, 1003493, 1314041, 1281289, M054740,  M112910, 1189518, 1360269, 1274102, 1339287, 1328548);   825210830 (1271357, 1313443, 1212278, 1262656, 1320727, 1264551, 1338468);   825211030 (1320728, 1313444, 1212279, 1265025, 1342362, 1293167, 1287813);   825211230 (1245260, 1253421, 1240940);   825211430 (1240941, 1253422)
Recalling firm:
Richard Wolf GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2018

VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81682
Lot/product code:
All expired, in-date, and future lots released.
Recalling firm:
ORTHO-CLINICAL DIAGNOSTICS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2018

VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. The VITROS HBeAg test should not be used to test cord blood samples. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81682
Lot/product code:
All expired, in-date, and future lots released.
Recalling firm:
ORTHO-CLINICAL DIAGNOSTICS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2018

VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81682
Lot/product code:
All expired, in-date, and future lots released.
Recalling firm:
ORTHO-CLINICAL DIAGNOSTICS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2018

GEM Coupler Forceps, GEM4183C, packaged individually.

Potential presence of rust on Coupler Forceps (GEM4183C).

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FDA has not published a risk classification for this recall yet.

Recall #:
81581
Lot/product code:
Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 13, 2018

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.

There is a potential the joint in the suspension of the device is insufficiently assembled.

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FDA has not published a risk classification for this recall yet.

Recall #:
82476
Lot/product code:
Serial numbers 100000000065406 to 100000000106685.
Recalling firm:
Stryker Communications
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2018

Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81595
Lot/product code:
GTIN Number - 10884521706606 Lot Numbers-  S7HG007KX S7HG008KX S7HG009KX S7HG032LX S7HG033LX S7HG034LX S7JG008LX S7JG009X S7JG012X S7KG012LX S7KG038QX S7LG009X S7MG010LX S7MG019X S8BG004X S8BG005X S8CG002X S8DG001X S8DG026X S8EG004X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2018

Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81595
Lot/product code:
GTIN Number - 10884521706583 Lot Numbers-  S7HG002X S7HG003X S7HG005KX S7HG006KX S7HG022LX S7HG023LX S7HG024LX S7HG025LX S7HG029LX S7HG040X S7HG041X S7HG045X S7HG049X S7JG007X S7JG011X S7JG033LX S7JG034X S7JG035X S7JG041LX S7JG042LX S7JG043LX S7JG044LX S7JG045LX S7JG046LX S7JG047LX S7KG023LX S7KG029X S7KG033X S7KG039X S7KG040X S7KG042X S7LG001X S7LG002X S7LG006X S7LG011X S7LG012X S7MG008LX S7MG009LX S7MG011X S7MG012X S7MG014X S7MG018X S7MG020X S7MG021X S7MG022PX S7MG023PX S7MG024X S7MG025X S7MG026X S8AG001X S8AG002X S8AG011X S8AG013X S8CG004X S8CG010X S8CG017X S8CG019PX S8CG022PX S8CG025X S8DG014LX S8DG015LX S8DG016LX S8DG017LX S8DG018LX S8DG024X S8DG027X S8EG005X S8EG009X S8EG010X S8EG011X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2018

Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81595
Lot/product code:
GTIN Number - 10884521706590 Lot Numbers-  S7HG001PX S7HG004KX S7HG010KX S7HG011KX S7HG012KX S7HG030LX S7HG031LX S7HG035LX S7HG039LX S7HG042LX S7HG043X S7JG006X S7JG010X S7JG013X S7JG014X S7KG008LX S7KG009LX S7KG010LX S7KG041X S7KG043X S7LG003X S7LG004X S7MG003X S7MG004LX S7MG017PX S7MG029X S8BG001X S8BG002X S8BG006X S8CG001X S8CG008LX S8CG009X S8CG018X S8CG023X S8DG019LX S8DG020LX S8DG021LX S8DG022LX S8DG023X S8DG025X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2018

Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist

Potentially lead to anchor breakage during insertion,

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FDA has not published a risk classification for this recall yet.

Recall #:
81819
Lot/product code:
Lots #: 10175216, 1075219, 10199557, and 10199558
Recalling firm:
Arthrex, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0312-2019
Lot/product code:
Lot # 3079500, exp. date 1/2020
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0317-2019
Lot/product code:
Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)