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Recalls affecting District of Columbia

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

16,214 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

▸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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

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

Undeclared milk

▸Full report
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.

▸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/virusAnnounced 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)
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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2018

GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation, -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

ALL 50 STATES
▸Full report

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

Recall #:
81075
Lot/product code:
Serial numbers: No UDI: SJA15150092HA SJA15150100HA SJA15150124HA SJA15150125HA SJA15150126HA SJA15150127HA SJA15150128HA SJA15150139HA SJA15170033HA SJA15170079HA SJA15170081HA SJA15170085HA SJA15170086HA SJA15170087HA SJA15170088HA SJA15170089HA SJA15170090HA SJA15170091HA SNE16060190HA SNE16110218HA SJA14127613HA SJA14127614HA SJA15262026HA SJA15262173HA SJA15272036HA SJA15282008HA SJA15282009HA SJA15282010HA SJA15282014HA SJA15282015HA SJA15282016HA SJA15282017HA SJA15282019HA SJA15282022HA SJA15282024HA SJA15282043HA SJA15282044HA SJA15282048HA SJA15282051HA SJA15282054HA SJA15282055HA SJA15282059HA SJA15282060HA SJA15282063HA SJA15282065HA SJA15282118HA SJA15282122HA SJA15282125HA SJA15282128HA SJA15282129HA SJA15282131HA SJA15282134HA SJA15282135HA SJA15282141HA SJA15282149HA SJA15382048HA SJA14437335HA SJA14437337HA SJA14127619HA SJA14127621HA SJA14127622HA SJA14127623HA SJA14127624HA SJA14127626HA SJA14392398HA SJA14392402HA SJA14192489HR SJA14302513HR SJA15401023HR SJA15170060HA SJA15170127HA SJA15170128HA SJA15170129HA SJA15170130HA SJA15170137HA SJA15292063HA SJA14473730HA SNE15480016HA SNE15480017HA SNE15480019HA SNE15511032HA SJA15342151HA SJA15342152HA SJA15252097HA SJA15252142HA SJA15252143HA SJA15252144HA SJA15252149HA SJA15252150HA SJA15252151HA SJA15262060HA SJA15262061HA SJA15262062HA SJA15262063HA SJA15262064HA SJA15262068HA SJA15262069HA SJA15262070HA SJA15452019HA SNE15431001HA SNE16010064HA SNE16010070HA SNE16010071HA SNE16010078HA SNE16010079HA SNE16010080HA SJA15262004HA SJA15262005HA SJA14403421HA SJA15101137HA SNE16110060HA SNE16110063HA SNE16110065HA SNE16110066HA SJA15262006HA SNE16080111HA SNE16080112HA SNE16080113HA SNE16080114HA SNE16080115HA SNE16080116HA SNE16080117HA SNE16080118HA SNE16080119HA SNE16080121HA SNE16050129HA SNE16050131HA SNE16120029HR SNE16120040HR SNE15520017HA SNE15520018HA SNE15520019HA SNE15520020HA SNE15520022HA SNE15531045HA SNE15531046HA SNE16010075HA SNE16010076HA SNE16010077HA SNE15520036HA SNE15520079HA SNE15520080HA SNE16080202HA SNE16080203HA SNE16080204HA SNE16080206HA SNE16080207HA SNE16090021HA SNE16090022HA SNE16090024HA SNE16090025HA SNE16090027HA SNE16090029HA SNE16090031HA SNE16090032HA SNE16130019HA SNE16130020HA SNE16130023HA SNE16130024HA SJA14138552HA SJA14138553HA SJA14138555HA SJA14138558HA SJA15120117HA SJA15120146HA SJA15120147HA SJA15120148HA SJA15120149HA SJA15120150HA SJA15120151HA SJA15120152HA SJA15120154HA SJA15120155HA SJA15120156HA SJA15120157HA SJA15120161HA SJA15120164HA SJA15120165HA SJA15120166HA SJA15120168HA SJA15140138HA SJA15140139HA SJA15140140HA SJA15140141HA SJA15140145HA SJA15140146HA SJA15140147HA SJA15140148HA SJA15101204HA SJA15101207HA SJA15101221HA SJA15101224HA SJA15101235HA SJA15101240HA SJA15101243HA SJA15121009HA SJA15044565HA SJA15044566HA SJA15044567HA SJA15044569HA SJA15044571HA SJA15101292HA SJA15101293HA SJA15112630HA SJA15112631HA SJA15112632HA SJA15112633HA SJA15112635HA SJA15112636HA SJA15112637HA SJA15112638HA SJA15112639HA SJA15112640HA SJA15170076HA SJA15066575HA SJA15066586HA SJA15066599HA SJA15066600HA SNE16121015HA SJA13507992HR SJA14415427HR SNE16191082HR SJA15222023HA SNE16090200HA SJA14358266HA SJA14358267HA SJA14379900HA SJA14379901HA SJA14472381HA SJA15302035HA SJA15302041HA SJA14403455HA SJA14403456HA SJA15031768HA SJA15031818HA SJA15031819HA SJA15033243HA SJA15033244HA SJA15033245HA SJA15066593HA SJA15090664HA SJA15090665HA SJA15090675HA SNE15450027HA SNE15450028HA SNE15450029HA SJA14460951HA SJA14460973HA SNE17251032HA SJA15382323HA SJA14414517HA SJA15020681HA SJA15322125HA SJA15322131HA SJA15332114HA SJA15332124HA SJA15332138HA SJA15332139HA SJA15332141HA SJA15332142HA SJA15332143HA SJA15332144HA SJA15332145HA SJA15332149HA SJA15332150HA SJA15332151HA SJA14291680HA SJA15171001HA SJA15171002HA SJA15171003HA SJA15171005HA SJA15171006HA SJA15291004HA SNE15511001HA SNE15511004HA SNE15511008HA SNE15511014HA SNE16021001HA SNE16021002HA SJA13507985HA SJA13508793HA SJA13508794HA SJA13508795HA SJA13019537HA SJA13508792HA SJA13508796HA SJA13508797HA SJA14314410HA SNE16110126HA SNE15490001HA SNE15490034HA SNE15490070HA SNE15520077HA SNE15520078HA SNE15520088HA SNE15520089HA SNE15520090HA SJA14459942HA SJA14507676HA SJA14507679HA SJA14507680HA SJA14507691HA SJA14507692HA SJA14507703HA SJA14507704HA SJA14519037HA SJA14519039HA SJA14519041HA SJA14519042HA SJA14519043HA SJA14519045HA SJA14519046HA SJA14519048HA SNE15511016HA SNE15531064HA SJA13519474HR SNE16181001HR SNE16181014HR SNE16181029HR SNE16181033HR SNE16181035HR SNE16181041HR SNE16181042HR SNE16181047HR SNE16181048HR SNE16181054HR SNE16181056HR SNE16181059HR SNE16181061HR SNE16181062HR SNE16181070HR SNE16191003HR SNE16191008HR SNE16191010HR SNE16191015HR SNE16191016HR SNE16191017HR SNE16191028HR SNE16191029HR SNE16191055HR SNE16191068HR SNE16191071HR SNE16191073HR SNE16191076HR SNE16191078HR SJA14381877HA SJA14381881HA SJA14381885HA SJA14392419HA SJA14392420HA SJA14392421HA SJA14392422HA SJA14392423HA SJA14392424HA SJA14392425HA SJA143… (truncated, 2210545 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare Finland Oy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2018

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

ALL 50 STATES
▸Full report

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

Recall #:
81055
Lot/product code:
UDI - 10607567108391 All Serial Numbers
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2018

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

ALL 50 STATES
▸Full report

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

Recall #:
81055
Lot/product code:
UDI - 10607567108407 All Serial Numbers
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
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

ALL 50 STATES
▸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 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - 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

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66631-A2443, 66631-A2564, 66631-A2629, 66631-A2772, 66631-A2975, 66631-A3004, 66631-A3311, 66631-A3456, 66631-A3483, 66631-A3553, 66631-A3558, 66631-A3738, 66631-A3774, 66631-A3795, 66631-A3978, 66631-A4082, 66631-A4148, 66631-A4444, 66631-A4517, 66631-A5065, 66631-A5282, 66631-A5411, 66631-A5555, 66631-A5670
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 Manifold, 1500mL, REF 66616 (Canadian distribution) - 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

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66616-A2442, 66616-A2524, 66616-A2725, 66616-A2906, 66616-A2974, 66616-A3033, 66616-A3309, 66616-A3310, 66616-A3318, 66616-A3520, 66616-A3554, 66616-A3559, 66616-A3737, 66616-A3773, 66616-A3794, 66616-A3977, 66616-A4081, 66616-A4147, 66616-A4443, 66616-A4516, 66616-A5064, 66616-A5281, 66616-A5410, 66616-A5550, 66616-A5669
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 Manifold, 4000mL, REF 66641 (Canadian distribution) - 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

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66641-A2630, 66641-A2683, 66641-A3005, 66641-A3560, 66641-A3796, 66641-A3979, 66641-A4220, 66641-A4473, 66641-A4543, 66641-A5066, 66641-A5283, 66641-A5412, 66641-A5556, 66641-A5671
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, 4000mL, (legless) REF 66640 - 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

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66640-A2404, 66640-A4324
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

ALL 50 STATES
▸Full report

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

ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 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

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: H938901 63615-A1768, H938901 63615-A1770, H938901 63615-A1772, H938901 63615-A2648, H938901 63615-A2650, H938901 63615-A2652, H938901 63615-A2653, H938901 63615-A2654, H938901 63615-A2656, H938901 63615-A2658, H938901 63615-A2660, H938901 63615-A2662, H938901 63615-A3951, H938901 63615- A3953, H938901 63615-A3955, H938901 63615-A3958, H938901 63615-A3960, H938901 63615-A3962, H938901 63615-A3964, H938901 63615-A3966, H938901 63615-A3967, H938901 63615-A5337, H938901 63615-A5339, H938901 63615-A5341, H938901 63615-A5343, H938901 63615-A5345, H938901 63615-A5347, H938901 63615-A5349
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
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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▸Full report

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 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

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▸Full report

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 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
▸Full report

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 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
▸Full report

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
▸Full report

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 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.

ALL 50 STATES
▸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 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 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.

ALL 50 STATES
▸Full report

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 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.

ALL 50 STATES
▸Full report

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 3, 2018

Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)

Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
81246
Lot/product code:
Serial Numbers NG1330099H NG1330154H NG1329859H NG1330107H NG1330110H NG1330113H NG1330122H NG1330133H NG1330136H NG1330140H NG1330142H NG1330143H NG1330145H NG1330160H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1330145H NG1330160H NG1330160H NG1330145H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1399727H NG1399183H NG1399310H NG1400412H NG1399761H NG1399740H NG1399750H NG1400409H NG1400138H NG1400067H NG1400445H NG1400080H NG1400332H NG1400078H NG1400458H NG1400416H NG1400350H NG1400420H NG1400003H NG1399926H NG1400448H NG1400674H NG1400159H NG1399266H NG1400140H NG1400562H NG1400509H NG1400346H NG1399206H NG1400293H NG1400164H NG1399776H NG1399708H NG1399738H NG1400077H NG1399562H NG1399623H NG1399101H NG1399268H NG1398858H NG1399624H NG1399345H NG1399574H NG1399614H NG1398932H NG1398948H NG1399462H NG1399530H NG1399210H NG1399441H NG1399997H NG1400051H NG1400054H NG1400106H NG1400292H NG1399923H NG1400072H NG1399663H NG1399669H NG1400151H NG1400353H NG1400410H NG1400434H NG1399757H NG1399680H NG1399890H NG1399622H NG1399674H NG1399613H NG1399892H NG1399015H NG1399389H NG1399467H NG1398249H NG1398312H NG1399185H NG1398301H NG1399497H NG1398015H NG1398434H NG1398130H NG1398062H NG1398063H NG1399103H NG1399175H NG1399107H NG1399352H NG1399527H NG1399176H NG1399443H NG1399472H NG1399202H NG1399057H NG1399182H NG1399271H NG1398692H NG1398937H NG1398670H NG1398550H NG1398795H NG1398647H NG1398751H NG1398667H NG1398555H NG1398646H NG1400170H NG1400154H NG1400282H NG1400160H NG1400148H NG1400438H NG1400482H NG1399894H NG1400512H NG1400481H NG1398852H NG1400471H NG1400513H NG1400569H NG1400206H NG1400477H NG1400575H NG1400068H NG1400572H NG1400480H NG1400344H NG1400473H NG1400453H NG1397889H NG1397914H NG1398297H NG1397901H NG1399354H NG1399284H NG1399633H NG1399445H NG1399495H NG1399413H NG1399636H NG1399054H NG1399020H NG1399195H NG1399196H NG1398467H NG1394992H NG1399334H NG1398931H NG1399079H NG1399213H NG1398385H NG1399180H NG1398839H NG1399058H NG1398919H NG1399113H NG1399435H NG1399494H NG1399384H NG1398800H NG1398455H NG1398444H NG1398470H NG1398435H NG1398304H NG1398443H NG1399407H NG1398293H NG1399567H NG1398918H NG1399019H NG1399375H NG1399312H NG1399320H NG1398032H NG1399379H NG1399318H NG1398940H NG1399083H NG1399177H NG1399313H NG1399012H NG1399204H NG1399105H NG1398084H NG1398289H NG1399404H NG1398910H NG1398451H NG1399246H NG1399188H NG1398728H NG1398237H NG1399056H NG1398832H NG1399021H NG1399569H NG1398439H NG1398502H NG1399263H NG1398475H NG1399564H NG1399016H NG1399416H NG1399095H NG1398936H NG1399339H NG1398305H NG1398433H NG1399186H NG1399256H NG1398650H NG1398663H NG1399707H NG1399615H NG1398464H NG1399244H NG1399218H NG1399080H NG1399013H NG1398553H NG1398569H NG1398563H NG1399084H NG1399474H NG1398941H NG1398909H NG1399250H NG1399051H NG1398915H NG1398837H NG1398817H NG1398857H NG1399565H NG1399248H NG1398928H NG1399323H NG1399216H NG1399259H NG1399634H NG1398916H NG1398924H NG1399629H NG1399748H NG1398828H NG1399491H NG1399448H NG1399492H NG1398759H NG1399452H NG1399252H NG1399401H NG1399575H NG1399187H NG1398694H NG1398677H NG1398544H NG1399332H NG1398673H NG1399091H NG1399576H NG1398792H NG1399418H NG1399017H NG1399100H NG1399493H NG1399289H NG1398438H NG1398763H NG1399050H NG1399208H NG1398860H NG1399225H NG1398652H NG1398686H NG1398691H NG1398651H NG1398695H NG1398566H NG1398515H NG1399692H NG1404598H NG1404947H NG1404897H NG1404932H NG1405462H NG1405014H NG1405246H NG1405244H NG1405377H NG1404732H NG1400167H NG1399671H NG1399925H NG1399916H NG1399991H NG1400050H NG1399928H NG1400411H NG1400045H NG1400172H NG1400446H NG1400162H NG1399743H NG1400284H NG1400046H NG1400042H NG1400436H NG1400005H NG1400287H NG1400424H NG1399993H NG1400312H NG1399184H NG1399709H NG1399573H NG1399885H NG1399566H NG1399934H NG1399999H NG1405228H NG1404682H NG1405263H NG1405242H NG1404756H NG1404895H NG1404726H NG1404617H NG1404728H NG1405042H NG1404520H NG1404892H NG1404625H NG1404938H NG1405510H NG1404785H NG1404944H NG1405291H NG1404940H NG1405223H NG1405190H NG1405248H NG1405285H NG1405229H NG1404840H NG1404879H NG1405261H NG1404655H NG1405376H NG1405237H NG1405293H NG1404965H NG1405450H NG1404687H NG1404953H NG1404823H NG1405232H NG1405257H NG1404731H NG1404700H NG1399719H NG1400070H NG1399882H NG1399617H NG1399621H NG1399714H NG1399777H NG1398793H NG1399759H NG1398649H NG1398917H NG1398853H NG1399090H NG1398834H NG1401004H NG1400737H NG1401014H NG1401012H NG1401016H NG1400701H NG1394712H NG1343244H NG1398802H NG1394999H NG1343246H NG1343253H NG1394985H NG1343249H NG1394967H NG1400682H NG1405554H NG1405378H NG1398812H NG1398738H NG1399053H NG1400734H NG1395001H NG1394982H NG1394997H NG1400546H NG1399342H NG1400063H NG1400044H NG1399896H NG1399905H NG1399198H NG1399178H NG1399659H NG1399898H NG1398863H NG1400064H NG1399772H NG1400069H NG1399316H NG1399631H NG1399918H NG… (truncated, 1638277 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)