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Recalls affecting Maryland

Data last updated: September 11, 2026 at 1:08 PM UTC

16,861 recalls found
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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

▸Full report
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

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
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.

View FDA’s announcement (opens in a new tab)
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

▸Full report
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

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
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

View FDA’s announcement (opens in a new tab)
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

▸Full report
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.

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
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

View FDA’s announcement (opens in a new tab)
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

▸Full report
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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
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/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2021

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm LSC5-045 P

The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

AKALARAZCACODCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNENHNJNMNVNYOHOKORPAPRRISCTNTXUTVAWAWIWV
▸Full report

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

Recall #:
89001
Lot/product code:
All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA1-000 PA0382-001 End Cap 887517001139 CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM 887517001146 CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM 887517001153 CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM 887517001160 CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM 887517001177 CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM 887517001184 CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM 887517001191 CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM 887517001207 CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM 887517001214 CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM 887517001221 CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM 812258028121 HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL 812258028138 HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL 812258028145 HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL 812258028152 HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL 812258028169 HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL 812258021337 LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm 812258021344 LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm 812258021351 LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm 812258021368 LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm 812258021375 LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm 812258021382 LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm 812258021399 LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm 812258021405 LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm 812258021412 LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm 00887517029027 LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg 00887517029010 LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg 00887517029003 LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg 00887517028990 LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg 00887517028983 LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg 00887517028976 LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg 00887517028969 LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg 00887517028952 LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg 00887517028945 LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg 856719002763 LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm 856719002770 LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm 856719002787 LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm 856719002794 LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm 856719002800 LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm 856719002817 LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm 856719002824 LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm 856719002831 LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm 856719002848 LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm 856719002886 LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm 856719002893 LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm 856719002909 LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm 856719002916 LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm 856719002923 LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm 856719002930 LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm 856719002947 LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm 856719002954 LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm 856719002961 LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm 856719002978 LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm 856719002985 LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm 856719002992 LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm 812258021429 LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm 812258021436 LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm 812258021443 LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm 812258021450 LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm 812258021467 LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm 812258021474 LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm 812258021481 LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm 812258021498 LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm 812258021504 LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm 00887517028938 LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg 00887517028921 LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg 00887517028914 LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg 00887517028907 LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg 00887517028891 LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg 00887517028884 LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg 00887517028877 LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg 00887517028860 LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg 00887517028853 LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg 812258021511 LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm 812258021528 LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm 812258021535 LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm 812258021542 LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm 812258021559 LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm 812258021566 LSC5-045 PP1742-045 Locking Screw, 5.0mm x 4 5… (truncated, 132877 characters total — see the official FDA record for the full value)
Recalling firm:
NuVasive Specialized Orthopedics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2021

Hanger-Bar 2P 45cm

The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential for a fall hazard.

ALL 50 STATES
▸Full report

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

Recall #:
89509
Lot/product code:
Part Number 72754 UPC Code: 881608800397 EAN Code: 7331599999707 Lot Number: 33218501
Recalling firm:
Human Care USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2021

Hanger-Bar 2P 45cm

The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential for a fall hazard.

ALL 50 STATES
▸Full report

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

Recall #:
89509
Lot/product code:
Part Number 72755 UPC Code: 881608800403 EAN Code: 7331599999714 Lot Number: 33164504
Recalling firm:
Human Care USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MEQ001 21AEQ00 21BEQ001 21BEQ002 21BEQ003 21CEQ001 21DEQ001 21DEQ002 21EEQ001 21EEQ002 21FEQ001 21FEQ002 21GEQ001 21HEQ001 21HEQ002 21JEQ001 21JEQ002. UDI: 50192253018989 (cs) 10192253018981 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MDQ014 21ADQ007 21CDQ004 21CDQ005 21DDQ001 21DDQ002 21EDQ001 21FDQ001 21GDQ001 21HDQ001 21JDQ003. UDI: 50192253018972 (cs) 10192253018974 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MBQ001 21ABQ001 21ABQ002 21BBQ002 21BBQ003 21BBQ004 21BBQ005 21CBQ002 21CBQ003 21DBQ003 21DBQ004 21DBQ005 21EBQ003 21EBQ004 21EBQ005 21FBQ002 21FBQ003 21FBQ004 21FBQ005 21HBQ001 21HBQ002 21JBQ002 UDI: 50192253018996 (cs) 10192253018998 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50192253018927 (Cs) 10192253018929 (Ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50885380172500 (cs) 10885380172502 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MMQ007 21BMQ007 21CMQ008 21DMQ001 21EMQ003 21FMQ007. UDI: 50192253006191 (cs) 10192253006193 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MJQ001 20MJQ002 21AJQ001 21AJQ002 21AJQ003 21AJQ004 21AJQ005 21AJQ006 21BJQ001 21BJQ002 21CJQ001 21DJQ001 21DJQ002 21DJQ003 21EJQ001 21EJQ002 21EJQ003 21EJQ004 21FJQ001 21FJQ002 21FJQ003 21GJQ001 21GJQ002 21HJQ001 21HJQ002 21HJQ003 21HJQ004 21HJQ005 21HJQ006 21JJQ001 21JJQ002 21JJQ003 UDI: 50885380172494 (cs) 10885380172496 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

ALL 50 STATES
▸Full report

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

Recall #:
88981
Lot/product code:
All serial numbers. UDI: 04953170339967
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 21CKQ001 21CKQ002 21HKQ001. UDI: 50192253005941 (cs) 10192253005943 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2021

OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

ALL 50 STATES
▸Full report

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

Recall #:
89176
Lot/product code:
Serial no. 0005, 0023
Recalling firm:
Haag-Streit USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2021

OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

ALL 50 STATES
▸Full report

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

Recall #:
89176
Lot/product code:
Serial no. 0157, 0158 & 0171
Recalling firm:
Haag-Streit USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH161002TY (01008406821216511117092521VH161002TY, H41212RL), VH161494JD (01008406821216511118011021VH161494JD, H41212RL), VH161911LV (01008406821216511118030021VH161911LV, H41212RL), VH163440GG (01008406821216511118121421VH163440GG, H41212YZ), VH261421ZS (01008406821216511120040021VH261421ZS, H41212YZ), VH162444U2 (01008406821216511118060021VH162444U2, H41212YZ), VH165272MV (01008406821216511119070021VH165272MV, H41212YZ), VH264483KQ (01008406821216511121011921VH264483KQ, H41212YZ), VH261426TR (01008406821216511120040021VH261426TR, H41212YZ), VH260601DD (01008406821216511120030021VH260601DD, H41212YZ), VH260693VL (01008406821216511120030021VH260693VL, H41212YZ), VH261300BX (01008406821216511120030021VH261300BX, H41212YZ), VH262303C1 (01008406821216511120061021VH262303C1, H41212YZ), VH1650459M (01008406821216511119060021VH1650459M, H41212YZ), VH26015148 (01008406821216511119120021VH26015148, H41212YZ), VH260359ZY (01008406821216511120030021VH260359ZY, H41212YZ), VH2605125L (01008406821216511120030021VH2605125L, H41212YZ), VH1617429V (01008406821216511118050021VH1617429V, H41212YZ), VH161794AP (01008406821216511118020021VH161794AP, H41212RL), VH165044C8 (01008406821216511119120021VH165044C8, H41212YZ), VH160828M8 (01008406821216511117080021VH160828M8, H41212RL), VH26143341 (01008406821216511120040021VH26143341, H41212YZ), VH264734WW (01008406821216511121020921VH264734WW, H41212YZ), VH163182CD (01008406821216511118090021VH163182CD, H41212YZ), VH265179EX (01008406821216511121040621VH265179EX, H41212YZ), VH163884HV (01008406821216511119031121VH163884HV, H41212YZ), VH260371WV (01008406821216511119120021VH260371WV, H41212YZ), VH260413XV (01008406821216511119120021VH260413XV, H41212YZ), VH261844IZ (01008406821216511120050521VH261844IZ, H41212YZ), VH1634495A (01008406821216511118110021VH1634495A, H41212YZ), VH265859FV (01008406821216511121071221VH265859FV, H41212YZ), VH266211S7 (01008406821216511121090821VH266211S7, H41212YZ), VH260422R5 (01008406821216511119120021VH260422R5, H41212YZ), VH261855IA (01008406821216511120050521VH261855IA, H41212YZ), VH262511X9 (01008406821216511120062521VH262511X9, H41212YZ), VH162672ZZ (01008406821216511118070021VH162672ZZ, H41212YZ), VH2603199C (01008406821216511120030021VH2603199C, H41212YZ), VH261392QA (01008406821216511120040021VH261392QA, H41212YZ), VH2614246U (01008406821216511120040021VH2614246U, H41212YZ), VH264744WA (01008406821216511121020521VH264744WA, H41212YZ), VH163373TQ (01008406821216511118110021VH163373TQ, H41212YZ), VH161230QP (01008406821216511117110021VH161230QP, H41212RL), VH163520B5 (01008406821216511118120021VH163520B5, H41212YZ), VH163543XL (01008406821216511118120021VH163543XL, H41212YZ), VH260572RJ (01008406821216511120030021VH260572RJ, H41212YZ), VH261820EA (01008406821216511120050521VH261820EA, H41212YZ), VH261451K8 (01008406821216511120040021VH261451K8, H41212YZ), VH261467NC (01008406821216511120040021VH261467NC, H41212YZ), VH261556JT (01008406821216511120040021VH261556JT, H41212YZ), VH1635644D (01008406821216511118120021VH1635644D, H41212YZ), VH163574GX (01008406821216511118120021VH163574GX, H41212YZ), VH163602RD (01008406821216511118120021VH163602RD, H41212YZ), VH165182SZ (01008406821216511119090021VH165182SZ, H41212YZ), VH165549SD (01008406821216511119090021VH165549SD, H41212YZ), VH1635656M (01008406821216511118120021VH1635656M, H41212YZ), VH2610751I (01008406821216511120040021VH2610751I, H41212YZ), VH261332S1 (01008406821216511120040021VH261332S1, H41212YZ), VH265083NK (01008406821216511121040621VH265083NK, H41212YZ), VH265941H1 (01008406821216511121071521VH265941H1, H41212YZ), VH162698PH (01008406821216511118070021VH162698PH, H41212YZ), VH16276523 (01008406821216511118070021VH16276523, H41212YZ), VH261336EQ (01008406821216511120040021VH261336EQ, H41212YZ), VH261388BN (01008406821216511120040021VH261388BN, H41212YZ), VH264603D7 (01008406821216511121020521VH264603D7, H41212YZ), VH262582C9 (01008406821216511120062921VH262582C9, H41212YZ), VH2625993T (01008406821216511120062521VH2625993T, H41212YZ), VH1614977P (01008406821216511118010021VH1614977P, H41212RL), VH161800BC (01008406821216511118020021VH161800BC, H41212RL), VH261513Z4 (01008406821216511120040021VH261513Z4, H41212YZ), VH162215VB (01008406821216511118050021VH162215VB, H41212YZ), VH165048BU (01008406821216511119060021VH165048BU, H41212YZ), VH2638216Q (01008406821216511120121421VH2638216Q, H41212YZ), VH2640834X (01008406821216511120121021VH2640834X, H41212YZ), VH2640875J (01008406821216511120121021VH2640875J, H41212YZ), VH264109NY (01008406821216511120121021VH264109NY, H41212YZ), VH264213B3 (01008406821216511120121421VH264213B3, H41212YZ), VH2642289A (01008406821216511120121421VH2642289A, H41212YZ), VH265978R2 (01008406821216511121080321VH265978R2, H41212YZ), VH266059Z5 (01008406821216511121080321VH266059Z5, H41212YZ), VH266118PA (01008406821216511121081921VH266118PA, H41212YZ), VH266145GN (01008406821216511121081921VH266145GN, H41212YZ), VH2… (truncated, 72034 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Console"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH1622261Y (01008406821216511118042621VH1622261Y, 5693455), VH161664XA (01008406821216511118031921VH161664XA, 5693455), VH2627194S (01008406821216511120071321VH2627194S, 5693455), VH160129E8 (01008406821216511117021721VH160129E8, 5693455), VH160834YQ (01008406821216511117110021VH160834YQ, 5693455), VH1642124F (01008406821216511119040921VH1642124F, 5693455), VH150152W7 (01008406821216511116080021VH150152W7, 5693455), VH160113JQ (01008406821216511117020321VH160113JQ, 5693455), VH161979EY (01008406821216511118030021VH161979EY, 5693455), VH162446PC (01008406821216511118061221VH162446PC, 5693455), VH161984GS (01008406821216511118030021VH161984GS, 5693455), VH161970GQ (01008406821216511118030021VH161970G, 5693455), VH1619899S (01008406821216511118030021VH1619899S, 5693455), VH160237FQ (01008406821216511117030021VH160237FQ, 5693455), VH1600005U (5693455), VH160007CX (5693455), VH160009UF (5693455), VH150153FK (5693455), VH161672SF (5693455), VH1624281N (5693455), VH150103AI (5693455), VH150150Z6 (5693455), VH160786JM (5693455), VH1608086P (5693455), VH1600107T (5693455), VH1607384V (5693455), VH1600112G (5693455), VH160012JB (5693455), VH1607406X (5693455), VH160742EX (5693455), VH1608215J (5693455), VH160633NC (5693455), VH160025HU (5693455), VH160744ZM (5693455), VH150151QA (5693455), VH160730NB (5693455), VH161629J2 (5693455), VH161631UU (5693455), VH160735W7 (5693455), VH161598QQ (5693455), VH1600189D (5693455), VH1501544T (5693455), VH160017E2 (5693455), VH150123AH (5693455), VH163240NI (5693455), VH160005HB (5693455), VH1656702Z (5693455), VH16567191 (5693455), VH1656729W (5693455), VH1656736Y (5693455), VH165674RL (5693455), VH165675AQ (5693455), VH165676D7 (5693455), VH1656777R (5693455), VH165678YC (5693455), VH165679H1 (5693455), VH150112VD (5693455), VH150113IF (5693455), VH1607343V (5693455), VH160012JB (5693455), VH150101S2 (5693455), VH160001S1 (5693455), VH160003N9 (5693455), VH1616079K (5693455), VH150105RI (5693455), VH150118BJ (5693455), VH1501144B (5693455), VH150119KV (5693455), VH150122PV (5693455), VH150104JE (5693455), VH150067PS (5693455), VH150102JE (5693455), VH16162756 (5693455), VH260391G7 (5693455), VH2609418F (5693455), VH26096618 (5693455), VH1600301G (5693455), VH160021FJ (5693455), VH160163HW (5693455)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (Model Number, Labeling, UDI)". VH162804HB (01008406821216511118070021VH162804HB, H41212ZA), VH261412UX (01008406821216511120040021VH261412UX, H41212ZA), VH261635DJ (01008406821216511120040021VH261635DJ, H41212ZA), VH261660DH (01008406821216511120040021VH261660DH, H41212ZA), VH262868PS (01008406821216511120071721VH262868PS, H41212ZA), VH162941AB (01008406821216511118090021VH162941AB, H41212ZA), VH266179UH (01008406821216511121081721VH266179UH, H41212ZA), VH164477C1 (01008406821216511119050021VH164477C1, H41212ZA), VH262930DV (01008406821216511120071721VH262930DV, H41212ZA), VH260225R9 (01008406821216511119120021VH260225R9, H41212ZA), VH16105885 (01008406821216511117100021VH16105885, H41212RN), VH1618109Q (01008406821216511118020021VH1618109Q, H41212RN), VH1618127M (01008406821216511118020021VH1618127M, H41212RN), VH162786AS (01008406821216511118072521VH162786AS, H41212ZA), VH163954E2 (01008406821216511119031921VH163954E2, H41212ZA), VH160716CP (01008406821216511117070021VH160716CP, H41212RN), VH160368VF (01008406821216511117032221VH160368VF, H41212RN), VH164216AP (01008406821216511119032721VH164216AP, H41212ZA), VH261981MJ (01008406821216511120081121VH261981MJ, H41212ZA), VH264256QP (01008406821216511120121821VH264256QP, H41212ZA), VH2657824M (01008406821216511121062321VH2657824M, H41212ZA), VH265885RM (01008406821216511121071621VH265885RM, H41212ZA), VH162822XP (01008406821216511118070021VH162822XP, H41212ZA), VH160402SS (01008406821216511117042421VH160402SS, H41212RN), VH165093DJ (01008406821216511119062821VH165093DJ, H41212ZA), VH261080RY (01008406821216511120030021VH261080RY, H41212ZA), VH261141GX (01008406821216511120030021VH261141GX, H41212ZA), VH162956I3 (01008406821216511118100021VH162956I3, H41212ZA), VH163189T6 (01008406821216511118100021VH163189T6, H41212ZA), VH2602335E (01008406821216511119120021VH2602335E, H41212ZA), VH260243BG (01008406821216511119120021VH260243BG, H41212ZA), VH260265CX (01008406821216511119120021VH260265CX, H41212ZA), VH162420Z9 (01008406821216511118050021VH162420Z9, H41212ZA), VH162788Z1 (01008406821216511118070021VH162788Z1, H41212ZA), VH265125Z4 (01008406821216511121032621VH265125Z4, H41212ZA), VH2600177X (01008406821216511119120021VH2600177X, H41212ZA), VH1632842M (01008406821216511118100021VH1632842M, H41212ZA), VH164854MH (01008406821216511119060021VH164854MH, H41212ZA), VH164938U3 (01008406821216511119060021VH164938U3, H41212ZA), VH262978UW (01008406821216511120073021VH262978UW, H41212ZA), VH2661816S (01008406821216511121081721VH2661816S, H41212ZA), VH160442KT (01008406821216511117050021VH160442KT, H41212RN), VH262836XX (01008406821216511120071621VH262836XX, H41212ZA), VH16263643 (01008406821216511118070021VH16263643, H41212ZA), VH162877XD (01008406821216511118070021VH162877XD, H41212ZA), VH1628794W (01008406821216511118080021VH1628794W, H41212ZA), VH163026KZ (01008406821216511118100021VH163026KZ, H41212ZA), VH163059LM (01008406821216511118100021VH163059LM, H41212ZA), VH163195M6 (01008406821216511118100021VH163195M6, H41212ZA), VH164636LU (01008406821216511119050021VH164636LU, H41212ZA), VH164657PH (01008406821216511119050021VH164657PH, H41212ZA), VH164708TI (01008406821216511119050021VH164708TI, H41212ZA), VH164721SC (01008406821216511119050021VH164721SC, H41212ZA), VH164740QH (01008406821216511119050021VH164740QH, H41212ZA), VH164748TN (01008406821216511119050021VH164748TN, H41212ZA), VH261627JV (01008406821216511120040021VH261627JV, H41212ZA), VH261687Z8 (01008406821216511120042121VH261687Z8, H41212ZA), VH262874VI (01008406821216511120071621VH262874VI, H41212ZA), VH262941EY (01008406821216511120072221VH262941EY, H41212ZA), VH263062I3 (01008406821216511120080421VH263062I3, H41212ZA), VH263682ER (01008406821216511120110221VH263682ER, H41212ZA), VH264146NR (01008406821216511121020421VH264146NR, H41212ZA), VH264255HC (01008406821216511120121821VH264255HC, H41212ZA), VH264671L1 (01008406821216511121020421VH264671L1, H41212ZA), VH265122D9 (01008406821216511121032621VH265122D9, H41212ZA), VH26546198 (01008406821216511121070521VH26546198, H41212ZA), VH2654891A (01008406821216511121061721VH2654891A, H41212ZA), VH265644PM (01008406821216511121070721VH265644PM, H41212ZA), VH265662TN (01008406821216511121061621VH265662TN, H41212ZA), VH265807VN (01008406821216511121070621VH265807VN, H41212ZA), VH2658316S (01008406821216511121070721VH2658316S, H41212ZA), VH265872PG (01008406821216511121072621VH265872PG, H41212ZA), VH265895LA (01008406821216511121072321VH265895LA, H41212ZA), VH265900VF (01008406821216511121071921VH265900VF, H41212ZA), VH265923UV (01008406821216511121080221VH265923UV, H41212ZA), VH265984RH (01008406821216511121080221VH265984RH, H41212ZA), VH265999UL (01008406821216511121080221VH265999UL, H41212ZA), VH266282UU (01008406821216511121091321VH266282UU, H41212ZA), VH162164RM (01008406821216511118050021VH162164RM, H41212ZA), VH2629271Q (01008406821216511120072921VH2629271Q, H41212ZA), VH263002BW (01008406821216511120072821VH263002BW, H412… (truncated, 638059 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH200176M2 (01008406821216511120080721VH200176M2, H41212ZD), VH150224FV (01008406821216511117040421VH150224FV, H41212RT), VH150359UT (01008406821216511118020021VH150359UT, H41212RT), VH150510JG (01008406821216511118110021VH150510JG, H41212ZD), VH150725FX (01008406821216511119031521VH150725FX, H41212ZD), VH150726PL (01008406821216511119031521VH150726PL, H41212ZD), VH150833LB (01008406821216511119050021VH150833LB, H41212ZD), VH2004729L (01008406821216511120122221VH2004729L, H41212ZD), VH200602E1 (01008406821216511121031021VH200602E1, H41212ZD), VH2007327J (01008406821216511121062921VH2007327J, H41212ZD), VH1504296K (01008406821216511118070021VH1504296K, H41212ZD), VH2001141J (01008406821216511120010021VH2001141J, H41212ZD), VH200727M4 (01008406821216511121061421VH200727M4, H41212ZD), VH200416DE (01008406821216511120111221VH200416DE, H41212ZD), VH1505184H (01008406821216511118120021VH1505184H, H41212ZD), VH200022GP (01008406821216511119120021VH200022GP, H41212ZD), VH150208XB (01008406821216511117040421VH150208XB, H41212RT), VH200663IW (01008406821216511121061521VH200663IW, H41212ZD), VH2006663X (01008406821216511121061521VH2006663X, H41212ZD), VH20071415 (01008406821216511121061721VH20071415, H41212ZD), VH200719LG (01008406821216511121061521VH200719LG, H41212ZD), VH150488AN (01008406821216511118110021VH150488AN, H41212ZD), VH200092VS (01008406821216511120010021VH200092VS, H41212ZD), VH200158ZR (01008406821216511120020021VH200158ZR, H41212ZD), VH20078872 (01008406821216511121072321VH20078872, H41212ZD), VH150329VP (01008406821216511118021321VH150329VP, H41212RT), VH200042EG (01008406821216511119120021VH200042EG, H41212ZD), VH1501645D (01008406821216511117052321VH1501645D, H41212RT), VH20049973 (01008406821216511120122221VH20049973, H41212ZD), VH150627JD (01008406821216511119012121VH150627JD, H41212ZD), VH1510213I (01008406821216511119110021VH1510213I, H41212ZD), VH200078CB (01008406821216511119120021VH200078CB, H41212ZD), VH200086VZ (01008406821216511120010021VH200086VZ, H41212ZD), VH200104JD (01008406821216511120030021VH200104JD, H41212ZD), VH2001402U (01008406821216511120020021VH2001402U, H41212ZD), VH200604XJ (01008406821216511121022421VH200604XJ, H41212ZD), VH20076953 (01008406821216511121072221VH20076953, H41212ZD), VH200772N5 (01008406821216511121072221VH200772N5, H41212ZD), VH150304YL (01008406821216511118020221VH150304YL, H41212RT), VH1504811P (01008406821216511118102221VH1504811P, H41212ZD), VH150483QI (01008406821216511118110121VH150483QI, H41212ZD), VH150486BT (01008406821216511118110121VH150486BT, H41212ZD), VH150487IA (01008406821216511118110421VH150487IA, H41212ZD), VH150717E8 (01008406821216511119031321VH150717E8, H41212ZD), VH150524EK (01008406821216511118120021VH150524EK, H41212ZD), VH150814W4 (01008406821216511119050021VH150814W4, H41212ZD), VH150815EB (01008406821216511119050021VH150815EB, H41212ZD), VH1508226B (01008406821216511119050021VH1508226B, H41212ZD), VH1508233A (01008406821216511119050021VH1508233A, H41212ZD), VH1509599D (01008406821216511119060021VH1509599D, H41212ZD), VH200035ND (01008406821216511119120021VH200035ND, H41212ZD), VH200439SJ (01008406821216511120120921VH200439SJ, H41212ZD), VH200668T6 (01008406821216511121061521VH200668T6, H41212ZD), VH200681YL (01008406821216511121061421VH200681YL, H41212ZD), VH2007231C (01008406821216511121061421VH2007231C, H41212ZD), VH200724YY (01008406821216511121061521VH200724YY, H41212ZD), VH200820FQ (01008406821216511121091721VH200820FQ, H41212ZD), VH150631WK (01008406821216511119030021VH150631WK, H41212ZD), VH1506566S (01008406821216511119030021VH1506566S, H41212ZD), VH150666EB (01008406821216511119030021VH150666EB, H41212ZD), VH150694FG (01008406821216511119030021VH150694FG, H41212ZD), VH150705HV (01008406821216511119030021VH150705HV, H41212ZD), VH1503974U (01008406821216511118050021VH1503974U, H41212ZD), VH15096421 (01008406821216511119070021VH15096421, H41212ZD), VH200777KC (01008406821216511121081621VH200777KC, H41212ZD), VH150852UQ (01008406821216511119050021VH150852UQ, H41212ZD), VH150933LR (01008406821216511119060021VH150933LR, H41212ZD), VH20014163 (01008406821216511120020021VH20014163, H41212ZD), VH200246AI (01008406821216511120070621VH200246AI, H41212ZD), VH200661SQ (01008406821216511121061521VH200661SQ, H41212ZD), VH150770V9 (01008406821216511119032621VH150770V9, H41212ZD), VH150685RS (01008406821216511119031521VH150685RS, H41212ZD), VH200643IQ (01008406821216511121030921VH200643IQ, H41212ZD), VH150197TZ (01008406821216511117041021VH150197TZ, H41212RT), VH150556H5 (01008406821216511118120021VH150556H5, H41212ZD), VH1502025B (01008406821216511117041021VH1502025B, H41212RT), VH150463BS (01008406821216511119012521VH150463BS, H41212ZD), VH150476N7 (01008406821216511118100021VH150476N7, H41212ZD), VH150478M9 (01008406821216511118100021VH150478M9, H41212ZD), VH15049949 (01008406821216511118110021VH15049949, H41212ZD), VH150939CY (01008406821216511119060021VH150939CY, H41212ZD), VH1… (truncated, 96433 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Sector USB"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH150315TI (01008406821216511118020021VH150315TI, H41212RR), VH15019235 (01008406821216511117033021VH15019235, H41212RR), VH150328FJ (01008406821216511118021321VH150328FJ, H41212RR), VH1503146U (01008406821216511118020921VH1503146U, H41212RR), VH1503356H (01008406821216511118021321VH1503356H, H41212RR), VH150318PI (01008406821216511118020821VH150318PI, H41212RR), VH2006357M (01008406821216511121031721VH2006357M, H41212ZB), VH1505402S (01008406821216511118120021VH1505402S, H41212ZB), VH150277MA (01008406821216511117100021VH150277MA, H41212RR), VH150278XK (01008406821216511119030221VH150278XK, H41212ZB), VH150280EN (01008406821216511117100021VH150280EN, H41212RR), VH15028191 (01008406821216511117100021VH15028191, H41212RR), VH150282CY (01008406821216511117100021VH150282CY, H41212RR), VH150283L3 (01008406821216511117100021VH150283L3, H41212RR), VH150296YP (01008406821216511118010021VH150296YP, H41212RR), VH150298DQ (01008406821216511118010021VH150298DQ, H41212RR), VH150299RZ (01008406821216511118010021VH150299RZ, H41212RR), VH15030049 (01008406821216511118010021VH15030049, H41212RR), VH150301JU (01008406821216511118010021VH150301JU, H41212RR), VH150305E7 (01008406821216511118020021VH150305E7, H41212RR), VH150325R6 (01008406821216511118020021VH150325R6, H41212RR), VH150332EL (01008406821216511118020021VH150332EL, H41212RR), VH150334AV (01008406821216511118020021VH150334AV, H41212RR), VH150356RI (01008406821216511118020021VH150356RI, H41212RR), VH150369TF (01008406821216511118020021VH150369TF, H41212RR), VH150396VW (01008406821216511118050021VH150396VW, H41212ZB), VH150398X2 (01008406821216511118050021VH150398X2, H41212ZB), VH1504078Q (01008406821216511118060021VH1504078Q, H41212ZB), VH150413SH (01008406821216511118060021VH150413SH, H41212ZB), VH1504145M (01008406821216511118060021VH1504145M, H41212ZB), VH150418YP (01008406821216511118060021VH150418YP, H41212ZB), VH15041959 (01008406821216511118110021VH15041959, H41212ZB), VH150498S4 (01008406821216511118110021VH150498S4, H41212ZB), VH1505015I (01008406821216511118110021VH1505015I, H41212ZB), VH1505026L (01008406821216511118110021VH1505026L, H41212ZB), VH150503FG (01008406821216511118110021VH150503FG, H41212ZB), VH150504PC (01008406821216511118110021VH150504PC, H41212ZB), VH150505WS (01008406821216511118110021VH150505WS, H41212ZB), VH150541JB (01008406821216511118120021VH150541JB, H41212ZB), VH150599H5 (01008406821216511119010021VH150599H5, H41212ZB), VH150603Q1 (01008406821216511119010021VH150603Q1, H41212ZB), VH1506321L (01008406821216511119030421VH1506321L, H41212ZB), VH150635LI (01008406821216511119030421VH150635LI, H41212ZB), VH150667SK (01008406821216511119040321VH150667SK, H41212ZB), VH150672TF (01008406821216511119040021VH150672TF, H41212ZB), VH150787F1 (01008406821216511119040021VH150787F1, H41212ZB), VH150788JE (01008406821216511119040021VH150788JE, H41212ZB), VH1503213I (01008406821216511118020021VH1503213I, H41212RR), VH150804V1 (01008406821216511119040021VH150804V1, H41212ZB), VH1506815J (01008406821216511119040021VH1506815J, H41212ZB), VH150409WM (01008406821216511118060021VH150409WM, H41212ZB), VH150753TC (01008406821216511119040421VH150753TC, H41212ZB), VH150421I5 (01008406821216511118080021VH150421I5, H41212ZB), VH200797WX (01008406821216511121090221VH200797WX, H41212ZB), VH150766CY (01008406821216511119050021VH150766CY, H41212ZB), VH20076196 (01008406821216511121090221VH20076196, H41212ZB), VH150520G8 (01008406821216511118120021VH150520G8, H41212ZB), VH2003248W (01008406821216511120091621VH2003248W, H41212ZB), VH150614LJ (01008406821216511119010021VH150614LJ, H41212ZB), VH1508428Q (01008406821216511119050021VH1508428Q, H41212ZB), VH200338JV (01008406821216511120091621VH200338JV, H41212ZB), VH1501821N (01008406821216511117030021VH1501821N, H41212RR), VH200729TM (01008406821216511121080521VH200729TM, H41212ZB)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.

The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.

ALL 50 STATES
▸Full report

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

Recall #:
88953
Lot/product code:
UDI 00763000185152
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Dual USB"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Nubmer)". VH1602482A (01008406821216511117040721VH1602482A, H41212RK), VH160398U2 (01008406821216511117040021VH160398U2, H41212RK), VH160910MS (01008406821216511117090021VH160910MS, H41212RK), VH160692PU (01008406821216511117060021VH160692PU, H41212RK), VH16072033 (01008406821216511117060021VH16072033, H41212RK), VH164639E1 (01008406821216511119060021VH164639E1, H41212YY), VH165023E4 (01008406821216511119090021VH165023E4, H41212YY), VH26557563 (01008406821216511121071221VH26557563, H41212YY), VH265583RM (01008406821216511121070921VH265583RM, H41212YY), VH2656017N (01008406821216511121070821VH2656017N, H41212YY), VH265638Q4 (01008406821216511121070921VH265638Q4, H41212YY), VH26564046 (01008406821216511121070921VH26564046, H41212YY), VH265645Q7 (01008406821216511121070821VH265645Q7, H41212YY), VH265647U2 (01008406821216511121070921VH265647U2, H41212YY), VH265836ZG (01008406821216511121071221VH265836ZG, H41212YY), VH265838JV (01008406821216511121071221VH265838JV, H41212YY), VH265842CE (01008406821216511121071221VH265842CE, H41212YY), VH265844SA (01008406821216511121070921VH265844SA, H41212YY), VH265845WV (01008406821216511121071221VH265845WV, H41212YY), VH265849MM (01008406821216511121070921VH265849MM, H41212YY), VH265851HS (01008406821216511121071221VH265851HS, H41212YY), VH26585212 (01008406821216511121070921VH26585212, H41212YY), VH265857ZW (01008406821216511121070921VH265857ZW, H41212YY), VH265858LY (01008406821216511121071221VH265858LY, H41212YY), VH265864P5 (01008406821216511121070921VH265864P5, H41212YY), VH1632681A (01008406821216511118100021VH1632681A, H41212YY), VH160462WV (01008406821216511117040021VH160462WV, H41212RK), VH160549FR (01008406821216511117060021VH160549FR, H41212RK), VH16055357 (01008406821216511117060021VH16055357, H41212RK), VH160673KV (01008406821216511117060021VH160673KV, H41212RK), VH160674YQ (01008406821216511117060021VH160674YQ, H41212RK), VH160717US (01008406821216511117060021VH160717US, H41212RK), VH160724UV (01008406821216511117110021VH160724UV, H41212RK), VH160844BL (01008406821216511117110021VH160844BL, H41212RK), VH160851T5 (01008406821216511117110021VH160851T5, H41212RK), VH160879LS (01008406821216511117090021VH160879LS, H41212RK), VH16090735 (01008406821216511117090021VH16090735, H41212RK), VH160911AW (01008406821216511117090021VH160911AW, H41212RK), VH16092049 (01008406821216511117090021VH16092049, H41212RK), VH160934IF (01008406821216511117090021VH160934IF, H41212RK), VH160940WS (01008406821216511117100021VH160940WS, H41212RK), VH160984TC (01008406821216511117100021VH160984TC, H41212RK), VH161007CG (01008406821216511117100021VH161007CG, H41212RK), VH161008JP (01008406821216511117100021VH161008JP, H41212RK), VH161028CS (01008406821216511117100021VH161028CS, H41212RK), VH1610527V (01008406821216511117100021VH1610527V, H41212RK), VH1610803G (01008406821216511117100021VH1610803G, H41212RK), VH161086VQ (01008406821216511117100021VH161086VQ, H41212RK), VH1610908L (01008406821216511117100021VH1610908L, H41212RK), VH16109229 (01008406821216511117100021VH16109229, H41212RK), VH161231L5 (01008406821216511117110021VH161231L5, H41212RK), VH161675YG (01008406821216511118030021VH161675YG, H41212RK), VH162475JG (01008406821216511118100021VH162475JG, H41212YY), VH162998CK (01008406821216511118100021VH162998CK, H41212YY), VH1630084S (01008406821216511118100021VH1630084S, H41212YY), VH1633236I (01008406821216511118110021VH1633236I, H41212YY), VH16065514 (01008406821216511117050021VH16065514, H41212RK), VH162006EW (01008406821216511118030021VH162006EW, H41212RK), VH165572VH (01008406821216511119080021VH165572VH, H41212YY), VH2631208T (01008406821216511120081721VH2631208T, H41212YY), VH263163KT (01008406821216511120081721VH263163KT, H41212YY), VH263287F8 (01008406821216511120081721VH263287F8, H41212YY), VH262239Y9 (01008406821216511120061221VH262239Y9, H41212YY), VH262110GZ (01008406821216511120060221VH262110GZ, H41212YY), VH262109PN (01008406821216511120060221VH262109PN, H41212YY), VH260405KN (01008406821216511119120021VH260405KN, H41212YY), VH261920X9 (01008406821216511120051821VH261920X9, H41212YY), VH263156PR (01008406821216511120091521VH263156PR, H41212YY), VH262014IC (01008406821216511120060221VH262014IC, H41212YY), VH262086QK (01008406821216511120052921VH262086QK, H41212YY), VH261683Q7 (01008406821216511120052921VH261683Q7, H41212YY), VH262773P1 (01008406821216511120070621VH262773P1, H41212YY), VH265406KA (01008406821216511121051821VH265406KA, H41212YY), VH263551YR (01008406821216511120101321VH263551YR, H41212YY), VH2630353P (01008406821216511120101321VH2630353P, H41212YY), VH263549DB (01008406821216511120101321VH263549DB, H41212YY), VH1632534K (01008406821216511118100021VH1632534K, H41212YY), VH160006DB (01008406821216511116080021VH160006DB, H41212RK), VH160022AZ (01008406821216511116080021VH160022AZ, H41212RK), VH264900CN (01008406821216511121030921VH264900CN, H41212YY), VH264904KF (01008406821216511121030921VH264904KF, H41212YY), VH1… (truncated, 5056 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.

ALL 50 STATES
▸Full report

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

Recall #:
88953
Lot/product code:
UDI 00763000186265
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)