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Recalls affecting Wyoming

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

16,303 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

▸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)
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 February 28, 2022

Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

ALL 50 STATES
▸Full report

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

Recall #:
89767
Lot/product code:
All Lots & Serial Numbers. V60 UDI-DI: 00884838009844, 00884838009851, 00884838020054, 00884838025776, 00884838089280, 00884838090996.
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 1, 2022

FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.

The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

ALL 50 STATES
▸Full report

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

Recall #:
89647
Lot/product code:
FORE-SIGHT ELITE Tissue Oximeter, Model Number 01-06-3000, UDI: 10609538630009; All Serial numbers.
Recalling firm:
Edwards Lifesciences, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 1, 2022

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

ALL 50 STATES
▸Full report

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

Recall #:
89647
Lot/product code:
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10, UDI: 00690103208573; All serial numbers.
Recalling firm:
Edwards Lifesciences, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2022

Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.

There is potential for the capsule bond to break during the procedure.

ALL 50 STATES
▸Full report

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

Recall #:
89754
Lot/product code:
HARMONY-DCS (GTIN: 00763000341367); Lot Numbers: 0010519040, 0010565921, 0010578123, 0010578126, 0010583884, 0010631963, 0010631969, 0010631971, 0010717000, 0010717001, 0010717002, 0010723188, 0010723189, 0010723190, 0010727345, 0010804938, 0010826589, (the following lots were added 4/22/2022) 0010826591, 0010826592, and 0010826593
Recalling firm:
Medtronic Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

ALL 50 STATES
▸Full report

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

Recall #:
89953
Lot/product code:
All lot numbers UDI: (01)00630414591056(10)13852076(17)20220115 (01)00630414591056(10)46894074(17)20211028 (01)00630414591056(10)89042083(17)20220805
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

ALL 50 STATES
▸Full report

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

Recall #:
89641
Lot/product code:
UDI: 00886874117309. All lots
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453 85454 85455 Product Code/UDI /Description: 85400 00650862854008 iCAST COVERED STENT,5MMX38MMX80CM 85401 00650862854015 iCAST COVERED STENT,5MMX59MMX80CM 85402 00650862854022 iCAST COVERED STENT,6MMX38MMX80CM 85403 00650862854039 iCAST COVERED STENT,6MMX59MMX80CM 85404 00650862854046 iCAST COVERED STENT,7MMX38MMX80CM 85405 00650862854053 iCAST COVERED STENT,7MMX59MMX80CM 85406 00650862854060 iCAST COVERED STENT,8MMX38MMX80CM 85407 00650862854077 iCAST COVERED STENT,8MMX59MMX80CM 85408 00650862854084 iCAST COVERED STENT,9MMX38MMX80CM 85409 00650862854091 iCAST COVERED STENT,9MMX59MMX80CM 85410 00650862854107 iCAST COVERED STENT,5MMX38MMX120CM 85411 00650862854114 iCAST COVERED STENT,5MMX59MMX120CM 85412 iCAST COVERED STENT,6MMX38MMX120CM 85413 00650862854138 iCAST COVERED STENT,6MMX59MMX120CM 85414 00650862854145 iCAST COVERED STENT,7MMX38MMX120CM 85415 00650862854152 iCAST COVERED STENT,7MMX59MMX120CM 85416 00650862854169 iCAST COVERED STENT,8MMX38MMX120CM 85417 00650862854176 iCAST COVERED STENT,8MMX59MMX120CM 85418 00650862854183 iCAST COVERED STENT,9MMX38MMX120CM 85419 00650862854190 iCAST COVERED STENT,9MMX59MMX120CM 85420 00650862854206 iCAST COVERED STENT,10MMX38MMX80CM 85424 00650862854244 iCAST COVERED STENT,10MMX38MMX120CM 85440 00650862854404 iCAST COVERED STENT,5MMX16MMX80CM 85441 00650862854411 iCAST COVERED STENT,5MMX22MMX80CM 85442 00650862854428 iCAST COVERED STENT 6MMX16MMX80CM 85443 00650862854435 iCAST COVERED STENT,6MMX22MMX80CM 85444 00650862854442 iCAST COVERED STENT,7MMX16MMX80CM 85445 00650862854459 iCAST COVERED STENT,7MMX22MMX80CM 85450 00650862854503 iCAST COVERED STENT,5MMX16MMX120CM 85451 00650862854510 iCAST COVERED STENT,5MMX22MMX120CM 85452 00650862854527 iCAST COVERED STENT,6MMX16MMX120CM 85453 00650862854534 iCAST COVERED STENT,6MMX22MMX120CM 85454 00650862854541 iCAST COVERED STENT,7MMX16MMX120CM 85455 00650862854558 iCAST COVERED STENT,7MMX22MMX120CM

Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction. ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.

ALL 50 STATES
▸Full report

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

Recall #:
89852
Lot/product code:
All lots
Recalling firm:
Atrium Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.

Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

ALL 50 STATES
▸Full report

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

Recall #:
89931
Lot/product code:
All lots GTIN: 08714729993605
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.

Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

ALL 50 STATES
▸Full report

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

Recall #:
89931
Lot/product code:
All lots GTIN: 08714729995753
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.

Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

ALL 50 STATES
▸Full report

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

Recall #:
89931
Lot/product code:
All lots GTIN: 08714729995746
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388 85389 85390 85391 85392 85394 85395 85396 85397 85398 85370 85371 85372 and 85379. Product Code/UDI /Description: 85320 650862853209 Advanta V12 Covered Stent, 5mm x 38mm x 80cm; 85321 650862853216 Advanta V12 Covered Stent, 5mm x 59mm x 80cm; 85322 650862853223 Advanta V12 Covered Stent, 6mm x 38mm x 80cm; 85323 650862853230 Advanta V12 Covered Stent, 6mm x 59mm x 80cm 85324 650862853247 Advanta V12 Covered Stent, 7mm x 38mm x 80cm; 85325 650862853254 Advanta V12 Covered Stent, 7mm x 59mm x 80cm; 85326 650862853261 Advanta V12 Covered Stent, 8mm x 38mm x 80cm; 85327 650862853278 Advanta V12 Covered Stent, 8mm x 59mm x 80cm; 85328 650862853285 Advanta V12 Covered Stent, 9mm x 38mm x 80cm; 85329 650862853292 Advanta V12 Covered Stent, 9mm x 59mm x 80cm; 85330 650862853308 Advanta V12 Covered Stent, 5mm x 38mm x120cm; 85331 650862853315 Advanta V12 Covered Stent, 5mm x 59mm x120cm; 85332 650862853322 Advanta V12 Covered Stent, 6mm x 38mm x120cm; 85333 650862853339 Advanta V12 Covered Stent, 6mm x 59mm x120cm; 85334 650862853346 Advanta V12 Covered Stent, 7mm x 38mm x120cm; 85335 650862853353 Advanta V12 Covered Stent, 7mm x 59mm x120cm; 85336 650862853360 Advanta V12 Covered Stent, 8mm x 38mm x120cm; 85337 650862853377 Advanta V12 Covered Stent, 8mm x 59mm x120cm; 85338 650862853384 Advanta V12 Covered Stent, 9mm x 38mm x120cm; 85339 650862853391 Advanta V12 Covered Stent, 9mm x 59mm x120cm; 85340 650862853407 Advanta V12 Covered Stent, 5mm x 16mm x 80cm; 85341 650862853414 Advanta V12 Covered Stent, 5mm x 22mm x 80cm; 85342 650862853421 Advanta V12 Covered Stent, 6mm x 16mm x 80cm; 85343 650862853438 Advanta V12 Covered Stent, 6mm x 22mm x 80cm; 85344 650862853445 Advanta V12 Covered Stent, 7mm x 16mm x 80cm; 85345 650862853452 Advanta V12 Covered Stent, 7mm x 22mm x 80cm; 85350 650862853506 Advanta V12 Covered Stent, 5mm x 16mm x 120cm; 85351 650862853513 Advanta V12 Covered Stent, 5mm x 22mm x 120cm; 85352 650862853520 Advanta V12 Covered Stent, 6mm x 16mm x 120cm; 85353 650862853537 Advanta V12 Covered Stent, 6mm x 22mm x 120cm; 85354 650862853544 Advanta V12 Covered Stent, 7mm x 16mm x 120cm; 85355 650862853551 Advanta V12 Covered Stent, 7mm x 22mm x 120cm; 85360 650862853605 Advanta V12 Covered Stent, 10mm x 38mm x 80cm; 85361 650862853612 Advanta V12 Covered Stent, 10mm x 59mm x 80cm; 85364 650862853643 Advanta V12 Covered Stent, 10mm x 38mm x 120cm; 85365 650862853650 Advanta V12 Covered Stent, 10mm x 59mm x 120cm; 85370 650862853704 Advanta V12 Large Diameter, 12mm x 29mm x 80cm; 85371 650862853711 Advanta V12 Large Diameter, 12mm x 41mm x 80cm; 85372 650862853728 Advanta V12 Large Diameter, 12mm x 61mm x 80cm; 85379 650862853797 Advanta V12 Large Diameter, 12mm x 29mm x 120cm; 85388 650862853889 Advanta V12 Covered Stent, 5mm x 32mm x 80cm; ;85390 650862853902 Advanta V12 Covered Stent, 7mm x 32mm x 80cm; 85391 650862853919 Advanta V12 Covered Stent, 8mm x 32mm x 80cm; 85392 650862853926 Advanta V12 Covered Stent, 9mm x 32mm x 80cm; 85394 650862853940 Advanta V12 Covered Stent, 5mm x 32mm x 120cm; 85395 650862853957 Advanta V12 Covered Stent, 6mm x 32mm x 120cm. 85396 650862853964 Advanta V12 Covered Stent, 7mm x 32mm x 120cm 85397 650862853971 Advanta V12 Covered Stent, 8mm x 32mm x 120cm 85398 650862853988 Advanta V12 Covered Stent, 9mm x 32mm x 120cm

Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction. ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.

ALL 50 STATES
▸Full report

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

Recall #:
89852
Lot/product code:
All lots
Recalling firm:
Atrium Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

ALL 50 STATES
▸Full report

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

Recall #:
89953
Lot/product code:
All lot numbers UDI: (01)00630414598857(10)53376082(17)20220521 (01)00630414598857(10)53377082(17)20220521 (01)00630414598857(10)70533084(17)20220804
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

ALL 50 STATES
▸Full report

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

Recall #:
89953
Lot/product code:
All lot numbers UDI: (01)00630414293639(10)01380084(17)20220804 (01)00630414293639(10)20299080(17)20220303
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

ALL 50 STATES
▸Full report

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

Recall #:
89953
Lot/product code:
All lot numbers UDI: (01)00630414574646(10)14530079(17)20220304 (01)00630414574646(10)53553079(17)20220304 (01)00630414574646(10)54118081(17)20220521 (01)00630414574646(10)62860081(17)20220521 (01)00630414574646(10)70552083(17)20220805 (01)00630414574646(10)76807076(17)20220115 (01)00630414574646(10)93281076(17)20220115
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

ALL 50 STATES
▸Full report

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

Recall #:
89641
Lot/product code:
UDI: 00886874115664. All lots
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

ALL 50 STATES
▸Full report

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

Recall #:
89953
Lot/product code:
All lot numbers UDI: (01)00630414573342(10)08930076(17)20220115 (01)00630414573342(10)10982085(17)20221108 (01)00630414573342(10)19929072(17)20210819 (01)00630414573342(10)20298079(17)20220304 (01)00630414573342(10)48171081(17)20220304 (01)00630414573342(10)53554081(17)20220521 (01)00630414573342(10)70551083(17)20220805 (01)00630414573342(10)76055076(17)20220115
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.

Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

ALL 50 STATES
▸Full report

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

Recall #:
89931
Lot/product code:
All lots GTIN: 08714729983514
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2022

Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

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

Recall #:
89953
Lot/product code:
All lot numbers UDI: 01)00630414598864(10)10054080(17)20220303 (01)00630414598864(10)10979086(17)20221107 (01)00630414598864(10)53378082(17)20220521 (01)00630414598864(10)70532084(17)20220804
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 4, 2022

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

Software issue resulting in temporary loss of central monitoring functionality.

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

Recall #:
89877
Lot/product code:
Unique Device Identifier (UDI) for US distribution: (01)04049098001878(11)200626(21)1OQ84F-01013(93)MS26800-40, (01)04049098001878(11)190516(21)1OQ80D-00211(93)MS26800-36, (01)04049098001878(11)191218(21)1OQ84F-00362(93)MS26800-37, (01)04049098001878(11)200323(21)1OQ84F-00617(93)MS26800-38, (01)04049098001878(11)190903(21)1OQ84F-00103(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00105(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00104(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00099(93)MS26800-37, (01)04049098001878(11)190807(21)1OQ84F-00065(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00081(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00120(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00080(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00070(93)MS26800-36, (01)04049098001878(11)200630(21)1OQ84F-01005(93)MS26800-40, (01)04049098001878(11)190730(21)1OQ80D-00059(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ84F-00043(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ7XL-00479(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ7XL-00427(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ80D-00010(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ7XL-00792(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ84F-00088(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ7XL-00067(93)MS26800-36, (01)04049098001878(11)200323(21)1OQ84F-00606(93)MS26800-38, (01)04049098001878(11)190830(21)1OQ84F-00110(93)MS26800-37, (01)04049098001878(11)190902(21)1OQ84F-00098(93)MS26800-36, (01)04049098001878(11)200911(21)1OQ84F-01196(93)MS26800-41, (01)04049098001878(11)200123(21)1OQ84F-00496(93)MS26800-37, (01)04049098001878(11)200123(21)1OQ84F-00483(93)MS26800-37, (01)04049098001878(11)200123(21)1OQ84F-00507(93)MS26800-37, (01)04049098001878(11)200123(21)1OQ84F-00480(93)MS26800-37, (01)04049098001878(11)191217(21)1OQ84F-00364(93)MS26800-38, (01)04049098001878(11)200304(21)1OQ84F-00559(93)MS26800-38, (01)04049098001878(11)200228(21)1OQ84F-00548(93)MS26800-38, (01)04049098001878(11)200313(21)1OQ84F-00575(93)MS26800-38, (01)04049098001878(11)200720(21)1OQ84F-01030(93)MS26800-40, (01)04049098001878(11)200121(21)1OQ84F-00485(93)MS26800-38, (01)04049098001878(11)200220(21)1OQ84F-00516(93)MS26800-38, (01)04049098001878(11)190506(21)1OQ80D-00193(93)MS26800-36, (01)04049098001878(11)191016(21)1OQ84F-00211(93)MS26800-36, (01)04049098001878(11)200124(21)1OQ84F-00481(93)MS26800-37, (01)04049098001878(11)200124(21)1OQ84F-00500(93)MS26800-37, (01)04049098001878(11)200420(21)1OQ84F-00828(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00826(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00803(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00830(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00796(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00832(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00824(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00806(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00829(93)MS26800-40, (01)04049098001878(11)200420(21)1OQ84F-00804(93)MS26800-40, (01)04049098001878(11)200911(21)1OQ84F-01243(93)MS26800-41, (01)04049098001878(11)200911(21)1OQ84F-01212(93)MS26800-41, (01)04049098001878(11)201117(21)1OQ84F-01461(93)MS26800-43, (01)04049098001878(11)201127(21)1OQ84F-01520(93)MS26800-43, (01)04049098001878(11)201127(21)1OQ84F-01456(93)MS26800-43, (01)04049098001878(11)201127(21)1OQ84F-01469(93)MS26800-43, (01)04049098001878(11)201209(21)1OQ84F-01375(93)MS26800-43, (01)04049098001878(11)201123(21)1OQ84F-01429(93)MS26800-43, (01)04049098001878(11)190702(21)1OQ80D-00338(93)MS26800-36, (01)04049098001878(11)190703(21)1OQ80D-00368(93)MS26800-36, (01)04049098001878(11)201113(21)1OQ84F-01428(93)MS26800-43, (01)04049098001878(11)201207(21)1OQ84F-01252(93)MS26800-43, (01)04049098001878(11)210115(21)1OQ84F-01598(93)MS26800-43, (01)04049098001878(11)200922(21)1OQ84F-01257(93)MS26800-41, (01)04049098001878(11)201214(21)1OQ84F-01378(93)MS26800-43, (01)04049098001878(11)200819(21)1OQ84F-01073(93)MS26800-40, (01)04049098001878(11)200123(21)1OQ84F-00482(93)MS26800-38, (01)04049098001878(11)191209(21)1OQ84F-00394(93)MS26800-37, (01)04049098001878(11)200605(21)1OQ84F-00932(93)MS26800-40, (01)04049098001878(11)200323(21)1OQ84F-00594(93)MS26800-38, (01)04049098001878(11)200323(21)1OQ84F-00602(93)MS26800-38, (01)04049098001878(11)190308(21)1OQ80D-00156(93)MS26800-36, (01)04049098001878(11)200806(21)1OQ84F-01118(93)MS26800-40, (01)04049098001878(11)200806(21)1OQ84F-01115(93)MS26800-40, (01)04049098001878(11)200806(21)1OQ84F-01130(93)MS26800-40, (01)04049098001878(11)190212(21)1OQ80D-00057(93)MS26800-36, (01)04049098001878(11)190213(21)1OQ80D-00062(93)MS26800-36, (01)04049098001878(11)200115(21)1OQ84F-00424(93)MS26800-38, (01)04049098001878(11)190703(21)1OQ80D-00361(93)MS26800-36, (01)04049098001878(11)190703(21)1OQ80D-00366(93)MS26800-36, (01)04049098001878(11)190830(21)1OQ84F-00107(93)MS26800-36, (01)04049098001878(11)19… (truncated, 20695 characters total — see the official FDA record for the full value)
Recalling firm:
Draegar Medical Systems, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled March 4, 2022

SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.

Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0856-2022
Lot/product code:
Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024
Recalling firm:
Fagron, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 4, 2022

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

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

Recall #:
89975
Lot/product code:
All lots: UL-AG-2110-05-Q UL-AG-2111-02-Q UL-AG-2112-01-Q UL-AG-2112-02-Q UL-AG-2201-03-Q
Recalling firm:
SML Distribution, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 4, 2022

GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.

During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.

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

Recall #:
89842
Lot/product code:
All GE Healthcare MR Systems. UDIs: 01008148480204781120092321QED3257; 01008148480204851119053021QED2493; 010088483808097321301223488; 010088483808097321301408170; (01)00846082115971(11)160923921)PG45; 01008148480200031117031321QED1184; 01008148480200031117052221QED1241; 01008148480200031117061221QED1268; 01008148480200031117082921QED1348; 01008148480200031118061521QED1775; 01008148480200031118072621QED1888; 01008148480200031118110721QED2090; 010081484802000311120010221QED2892; 010081484802000311120090121QED3227; 01008148480208071921QED1881; 01008148480202491118091321QED1990; 01008148480202491118110121QED2080; 01008148480202491119021421QED2282; 01008148480202491119022121QED2296; 01008148480202491119061321QED2525; 01008148480202491119062821QED2548; 01008148480202491119080121QED2598; 01008148480202491119082921QED; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111. US System ID numbers: 3422, 00506MRS01, 030022MR01, 1000000047, 1000000576, 1000001238, 1000001348, 1000002760, 1000004048, 1000004074, 1000004278, 1000004288, 1000004456, 1000004458, 1000004646, 1000004953, 1000004954, 1000004956, 1000004986, 1009000, 1118313, 1323566, 201261MR, 201418MR2, 201445750W, 201447MRW, 201456MRX, 201579MRW, 201632MR, 201634MRW, 201639MR3T, 201669MR2, 201730MR, 201773MR, 201836MRW, 201840MR, 201858MRW, 201871MR, 201894GEMR, 201967MR, 202223MR, 202269MR, 202476MR2, 202476MR4, 202476MR5, 202715MR2, 202715MR3, 202865MR3T, 202966MR3TW, 203276ART, 203276MR, 203319MR, 203325MR4, 203325MR450W, 203327MR3T, 203337MREXP, 203453MR1, 203453VOYAGER, 203574MR450W, 203576MR2, 203694MR3T, 203739DDI3T, 203739MR450W, 203834VOYAGER, 203837MR450W, 203855MR3T, 203863MR450W, 203949MR3T, 205206MR1, 205251MR1, 205280MR1, 205295MR1, 205333MR1, 205345MRI, 205428MR, 205450WSMR, 205460SMR1, 205486MR1, 205487MR2, 205592450W, 205592750, 205608MR, 205702450W, 205750MR6, 205783450W, 205801KMR3, 205814MR1, 205822MR1, 2058773T, 205877450W, 205877MR2, 205933MRI1, 205934CVMR, 205939450W, 205939MR2, 205949MR450W, 205991MR2, 2059953T, 205995MRI, 205LMK450W, 205SBMR, 206223VM750W, 206223VMR1, 206244HM450, 206244HMR2, 206288SCCMR, 206292SR750W, 2063203TMR, 206373MR, 206386SMR, 206744HMR, 206762VAMR, 206781SB750W, 207255HD16MR, 207338MR450W, 207778ARTIST, 207945MR750, 207INTERMEDDVMR, 207MIDCOASTMR, 207MMCSMR, 207OA430MR, 208265BGMR, 208367LX10C, 208367LX11, 208367LX12, 208367LX14, 208367LX4, 208367LX6, 208367LX7, 208367LX8, 208367LX9, 208373MR, 208422MR1, 208463SZMR, 208529MR1, 208557MRI, 208678MR, 208743ART, 208743LOAMR, 208785MR, 208882MR450W, 209225VC750, 209333MR, 209491SSMR, 209521SGMR, 209526KMR, 209526SMMR, 209536SMR, 209577MRMR, 209754MR, 209832MR, 209847ONI, 209952SGMR, 209EMR, 209LBMR, 209MTMR, 209SJMR, 209SUTAMDMR, 210208MOMR, 210297SLMR, 210351HDMR, 210545SOMR, 210572CIMR, 210590NEHDMR, 210614NWMRLX, 210616MRLX, 210617HUBMR, 210617TCAMR2, 210681MSWHMR, 210737MR, 210804SUNMR, 210921GMR, 210921SWGMR, 210974NCBMR, 210ALMRI, 210BAMCMR1, 210LAFB750, 210MSMTMR, 210MSNWPMR, 210MSSPMR, 210OICRV, 210VHSART, 210WHASCMR2, 212255MR, 212288GE3T, 212288GEMR2, 212305MR5, 212312MR, 212420MR2, 212477MR, 212523MR3, 212523MRLX, 212535MR1, 212543PREMIER, 212562MR1, 212722HDXMR1, 21277MR1, 212844MRP, 212860EXTMR, 212989MR1, 212HDX2, 213202MR, 213340MR, 213387MR, 213426MR1, 213748HDMR, 213777MR, 213825DVMR4, 213829MR2, 213977MR, 213977MR2, 214214ABSMR1, 214220WBCMR1, 214265MINVMR1, 214265TXOMR1, 214266PCBCMR1, 214276MR1, 214302PDWMR1, 214329PHIMR1, 214341PDDMR2, 214341PDGPMR1, 214369TMR, 214369TSMR1, 214420MR1, 214433TNMR, 214559SRHMR1, 214619LSFMR1, 214645UT3TMR1, 214742VAMR1, 214794WMR1, 214820IMR1, 214820TS750WMR, 214820TSJMR2, 214828MPMR1, 214879INVIVO, 214947LXMR2, 214947MR2, 215111MR, 215201MR, 215248HD, 215277MRP, 215291LX, 215322MR2, 215331LXMR, 215453MR, 215464MR, 215481MR, 215543MR1, 215612HD, 215662MRA, 215663HD, 215674OP450W, 215707VOYAGER, 215750MR, 215829MR1, 215836LX, 215879MR, 215949MR, 215952LX, 215955MR3, 215955MR3G, 215997MR2, 215ARIA450W, 215DOY430S, 215FCCCMR3T, 215JEANESMR, 215VETMR, 216362MR, 216739MR3T, 216841MR, 216944MR2, 217223BHMR, 217258PMR, 217258SBMR2, 217347SAMR1, 217366CMR1, 217383CMR1A, 217383EDMR, 217528MR1, 217528MR2, 217532DVMR, 217732LMR, 217753MR1, 217753SMR1, 217876FMR, 217876MR2, 217BHC450W, 217QMG3TMR, 217QMGVOYAGER, 218249ART15, 2187493T, 218828MR, 219326MR450W, 219356MR, 219435MR, 219736SLMR2, 219738DVMR, 219756PHMR, 219845MR, 219865MRI, 219877MR, 219LBJMR, 224287MR, 224470MR, 225261MR, 225298MR, 225381MR, 225658LMR, 225751PROMR, 225755MRI, 225761MR2, 225763MR, 225763MR2, 225769BRCMR, 225769MRI, 225BRIMR, 225ICL450W, 225OHGMRI, 225OPMR, 225SJMR, 2277, 228818DVMR, 228BIENDVMR, 228CDLKMR, 229226PMR, 229228450W, 229228ARTIST, 229276MR, 229312MMRI, 229336MOB1, 229377MR1, 229386MR1, 229888AMR, 239254MR, 239292MR1, 239307MR, 239458MR1, 239482PRO, 239768MR, 239936MR, 239AHCMR, 239MEIMR1, 239NH… (truncated, 50679 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 March 7, 2022

SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan

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

Recall #:
89901
Lot/product code:
Software syngo CT VA30A_SP4 Serial numbers: 106115 106133 106237 106260 106360 106400 106459 106464 106484 106526 106527 106545 106562 108054 108056 108062 108076 108080 108085 108088 108095 108099 108101 108106 108108 108109 108111 108112 108113 108114 108116 108117 108118 108120 108125 108126 108128 108133 108146 108154 108158 108163 108168 108170 108174 108175 108176 108177 108178 108183 111219 111230 111232 111233 111236 111237 111249 111250 111266 111271 111273 111277 111281 111286 111289 111293 111297 111299 111302 111306 111308 111310 111313 111315 111317 111319 111323 111328 111339 111341 111345 111350 111351 111352 111355 111366 111367 111368 111369 111370 111371 111373 111378 111379 111381 111383 111386 111391 111394 111397 111398 111409 111413 111415 111416 111417 111420 111421 111426 111427 111428 111437 111438 111440 111441 111445 111446 111450 111452 111453 111454 111458 111460 111463 111465 111466 111469 111477 111485 111490 111491 111503 111504 111507 111510 111511 111514 111515 111523 111525 111532 111539 111542 111546 111550 111560 111562 111564 111578 111580 111582 111586 111587 111590 111617 111634 111644 111653 111703 111712 111717 111718 111726 111754 111757 111770 111773 111780 111794 111805 111814 111815 111824 111837 111862 111901 111904 111907 111927 111940 111965 111973 111974 111980 111981 111985 111986 111989 112000 112008 112013 112023 112030 112031 112035 112040 112045 112057 112059 112060 112061 112070 112071 112074 112077 112086 112088 112101 112103 112105 112112 112118 112139 112140 112149 112156 112157 112159 112166 112173 112179 112180 112182 112190 112518 112519 112541 112542 112545 112551 112552 112555 112573 112574 112577 112578 112579 112588 112591 112598 112610 112614 112632 112682 112705 112744 112765 112773 112779 112786 112861 117479 117482 117483 117484 117492 117495 117505 117508 117510 117515 117516 117520 117521 117522 117523 117529 117547 117557 117558 117560 117567 117570 117577 117582 117583 117586 117592 117600 117602 117605 117610 117611 117612 117615 117622 117623 117626 117633 117636 117637 117642 117644 117646 117648 117657 117674 117686 117692 117693 117708 117730 117732 117734 117739 117745 117750 117757 117774 117778 117780 117782 117784 117785 117787 117789 117794 117795 117800 117802 117813 117817 117824 117833 117834 117838 117849 117857 117858 117862 117865 117878 117880 117885 117889 117896 118151 119081 119083 119084 119085 119086 119087 119088 119090 119093 119098 119111 119115 119120 119122 119123 119125 119132 119133 119141 119143 119144 119145 119148 119152 119153 119157 119158 119173 119178 119180 119181 119190 119192 119197 119198 119200 119201 119208 119209 119213 119214 119217 119220 119227 119231 119234 119235 119237 119238 119239 119243 119254 119259 119261 119263 119264 119268 119271 119284 119290 119301 119317 119318 119319 119328 119330 119339 119346 119361 119386 119387 119388 119389 119400 119409 119410 119412 119419 119429 119435 119437 119439 119451 119471 119472 119475 119480 119482 119484 119485 119491 119500 119501 119512 119528 119540 119544 119548 119562 119574 119580 119582 119599 119616 119622 119623 119630 119631 119633 119634 119637 119639 119646 119661 119663 119671 119679 119694 119722 119724 119739 119740 119745 119749 119751 119752 119754 119761 119764 119769 119770 119773 119776 119778 119780 119781 119786 119794 119795 119805 119806 119828 119841 119866 119870 119871 119876 119877 119878 119884 119887 119891 119895 119913 123054 123055 123059 123060 123069 123104 123118 123122 123129 123130 128015 128016 128029 128035 128039 128041 128046 128049 128051 128057 128063 128068 128075 128085 128086 128088 128097 128098 128099 128100 128101 128102 130012 130015 130021 130022 130036 130039 130044 130048 130052 130054 130057 130059 130061 130063 130065 168108 168163 172508 172512 172518 172520 172532 172537 172550 UDI: SOMATOM go.Now 04056869051291 & 04056869051307 SOMATOM go.Up 04056869051314 & 04056869051321 SOMATOM go.All 04056869151564 & 04056869151588 SOMATOM go.Top 04056869151571 & 04056869151595 SOMATOM go.Sim 04056869249230 & 04056869239736 SOMATOM go.Open Pro 04056869249247 & 04056869239743 SOMATOM X.cite 04056869231044
Recalling firm:
Siemens Medical Solutions USA, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled March 7, 2022

YSIO X.Pree

For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.

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

Recall #:
89738
Lot/product code:
11107464
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 7, 2022

Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,

Transducers (component of ultrasound system) may exceed recommended thermal index limits

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

Recall #:
89856
Lot/product code:
UDI/DI - (01)4056869243566; Affected Serial Numbers: BT10672 BT10582 BT10617 BT10643 BT10669 BT10580 BT10619 BT10659 BT10611 BT10612 BT10614 BT10673 BT10581 BT10494 BT10610 BT10641 BT10497 BT10615 BT10661 BT10667 BT00248 BT10613 BT10657 BT10640 BT10584 BT10488 BT10481 BT10644
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)