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Recalls affecting North Dakota

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

16,332 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 Mendietary 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 AliveMoringa 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. Braun0.9% 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 ValueOrganic 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

LipofitLipofit 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

KofinasGarlic 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 TemptationsChocolatey 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 SproutsRobust 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

MartinaMangoes

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 September 10, 2017

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

ALL 50 STATES
Full report

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

Recall #:
78125
Lot/product code:
Lot Numbers: 5179979 5182542 5185471 5187173 5188894 5189581 5191349 5192467 5178077 5189588 5181137 5181140 5184757 5184758 5186199 5186203 5188890 5191350 5193510 5186206 5179854 5179857 5179975 5181712 5182176 5182543 5183121 5185154 5185157 5186200 5186201 5186202 5187102 5187170 5188889 5188893 5190033 5190708 5190710 5191351 5192470 5192679 5194101 5168207 5189592 5175824 5176442 5179855 5179977 5181711 5181713 5182177 5182179 5182544 5183122 5183123 5184087 5185155 5185156 5187101 5187171 5187817 5188886 5188887 5188888 5188895 5189583 5189584 5189585 5189586 5190031 5190707 5190709 5192468 5192469 5192471 5192680 5192691 5192692 5193308 5194100 5178081 5185473 5186207 5187821 5189590 5191354 5178084 5183072 5185153 5187103 5187818 5187819 5187820 5188892 5193505 5178076 5189591 5175953 5181138 5185472 5187172 5191352 5192682 5186205 5181139 5186204 5189587
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2017

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

ALL 50 STATES
Full report

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

Recall #:
78125
Lot/product code:
Lot Numbers: 5079672 5079674 5079675 5079697 5079698 5082268 5082622 5082773 5084125 5084460 5084464 5085187 5086974 5087586 5088981 5091305 5095068 5095069 5095177 5095195 5097241 5097967 5098225 5101297 5101624 5103311 5103312 5103409 5103888 5104247 5104632 5106185 5109341 5109702 5109707 5109788 5109789 5109790 5109791 5115440 5115456 5117215 5117935 5119233 5119933 5122173 5122398 5123224 5123228 5123253 5123254 5127870 5127932 5129136 5130064 5130084 5131255 5131853 5131854 5132018 5132951 5133982 5134548 5135127 5135128 5135176 5139007 5140383 5140384 5141588 5143411 5143418 5143983 5143984 5146890 5147485 5148153 5148887 5149493 5150551 5150591 5151310 5151829 5152526 5152962 5153937 5154653 5156088 5156857 5157422 5158190 5158191 5161065 5162223 5162250 5162886 5163245 5163931 5163949 5166387 5167139 5167818 5167819 5169320 5169321 5174510 5176569 5176581 5177287 5178033 5180040 5180041 5068343 5119941 5127869 5127940 5140277 5140347 5150562 5153947 5162256 5165229 5167006 5169334 5175719 5180060 5078337 5079699 5079702 5082269 5082270 5082627 5082774 5082775 5084126 5084127 5084462 5085476 5086923 5087587 5087588 5088385 5088386 5088612 5088613 5088982 5088983 5088984 5088985 5091306 5091307 5095070 5095071 5095072 5095181 5095183 5095196 5095197 5096419 5096420 5096423 5097242 5097968 5098226 5098599 5098828 5099489 5099719 5099720 5100589 5100590 5101625 5101626 5103313 5103314 5103315 5103889 5104633 5104634 5105363 5105364 5105437 5106827 5106828 5107548 5109709 5109711 5109792 5109793 5109794 5109795 5109796 5115441 5115444 5115454 5115455 5117039 5117216 5117267 5117936 5117937 5117938 5117939 5118541 5119234 5119663 5119934 5120632 5120633 5122399 5122400 5122401 5122402 5123226 5123227 5127871 5128409 5128411 5128412 5128413 5128448 5128449 5129142 5130065 5130066 5130067 5131256 5131257 5131855 5131856 5131857 5131858 5132095 5132099 5132952 5132953 5133983 5133984 5134433 5134549 5134550 5135129 5135130 5135131 5136421 5137569 5137570 5137881 5139008 5139009 5140271 5140385 5140386 5140387 5140388 5140389 5140391 5140392 5141466 5141511 5141512 5143412 5143985 5143986 5143987 5143988 5143989 5144245 5146891 5147486 5147487 5149494 5149495 5149496 5150428 5150471 5150472 5150473 5151301 5151830 5151831 5151832 5152963 5152964 5153938 5154654 5154655 5155461 5155462 5156446 5156447 5157364 5157371 5157372 5157423 5157424 5158192 5158193 5158194 5158195 5161066 5161067 5161460 5161461 5161815 5162224 5162225 5162251 5162252 5162889 5163246 5163247 5163258 5163932 5164574 5164575 5165202 5165203 5165204 5165990 5165991 5167802 5167803 5167804 5167805 5167806 5169322 5169323 5170778 5172578 5172579 5172580 5174511 5174512 5174513 5174514 5174515 5175706 5175707 5175708 5176470 5176471 5177285 5177286 5177288 5177289 5178180 5178181 5178182 5178183 5180042 5180045 5180046 5104249 5106559 5107119 5115452 5122416 5122417 5128451 5146898 5148922 5154662 5163261 5165960 5167136 5178184 5078343 5079703 5081819 5084130 5084466 5088387 5088986 5094245 5095073 5095204 5097243 5098829 5105435 5106186 5109718 5109797 5109798 5115457 5117217 5118542 5118929 5122174 5122403 5122581 5127872 5129134 5130068 5130069 5131258 5131859 5135132 5135133 5135134 5136422 5138172 5139010 5140393 5140394 5141470 5143413 5143990 5147488 5150558 5151302 5153939 5154270 5155463 5156832 5157425 5158196 5163933 5165206 5165957 5167807 5169324 5174516 5177290 5180047 5181092 5077112 5077135 5078333 5078335 5079704 5081818 5082271 5082776 5082777 5085188 5085189 5086975 5087589 5088389 5088989 5090810 5091221 5091308 5091309 5095074 5095206 5095587 5096424 5097244 5097969 5098227 5098830 5101627 5103316 5103317 5103890 5105444 5105446 5106187 5106188 5106829 5107549 5109799 5109800 5109801 5109802 5115442 5115443 5117041 5117218 5117219 5117246 5117940 5118543 5119235 5119935 5120634 5122175 5122404 5122405 5122582 5123230 5123240 5123241 5129131 5129132 5129133 5129486 5130070 5131259 5131860 5131861 5132965 5133985 5135135 5135136 5135470 5136423 5137370 5137876 5138173 5139011 5140272 5140395 5140396 5141586 5141601 5143414 5143674 5143991 5143992 5146899 5147489 5148154 5148444 5148888 5150474 5150475 5151276 5151303 5151833 5151834 5152541 5152965 5153940 5154656 5156448 5156833 5157370 5157426 5157427 5158197 5158198 5161074 5161814 5162024 5162253 5163248 5163950 5163951 5164576 5166402 5167808 5170779 5170780 5174517 5174518 5175704 5175709 5176568 5176577 5178025 5178186 5180048 5068344 5090864 5113373 5119959 5120571 5127937 5127941 5140278 5140346 5150563 5151309 5162257 5162869 5169335 5170600 5174531 5176575 5180061 5078266 5078938 5079676 5079678 5079707 5079708 5079709 5082272 5082441 5082442 5082446 5082615 5082616 5082778 5084128 5084129 5084468 5084469 5084470 5084471 5084633 5084634 5085190 5085191 5086976 5087590 5088390 5088391 5088605 5088992 5088993 5088994 5088996 5091222 5091223 5091310 5091311 5093159 5093160 5095075 5095076 5095077 5095078 5095185 5095200 5095201 5095202 5096425 5096426 5097137 50… (truncated, 11509 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2017

Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

ALL 50 STATES
Full report

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

Recall #:
78125
Lot/product code:
Lot Numbers: 5188321 5190185 5190186 5184968 5185467 5185468 5185469 5185470 5188322 5188323 5188324 5188325 5188326 5188327 5188328 5189476 5189477 5189478 5189521 5189522 5190187 5190188 5190189 5191046 5191047 5191355 5192532 5183060 5183061 5187300 5187301 5187556 5187557 5189051 5193052 5188329 5188330 5189053 5189054 5194937 5185690 5187558 5191357 5187559
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2017

Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078

1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.

ALL 50 STATES
Full report

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

Recall #:
79426
Lot/product code:
Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2017

Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.

ALL 50 STATES
Full report

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

Recall #:
79426
Lot/product code:
Lot #: a) H1190448, Exp 7/31/2020, UDI (01)00884450328620(17)200731(10)H1190448; b) H1193585, Exp 5/30/2019, UDI (01)00884450328620(17)190530(10)H1193585
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2017

Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.

ALL 50 STATES
Full report

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

Recall #:
79426
Lot/product code:
Lot #: a) H1136644, Exp 12/31/2018, UDI (01)00884450305850(17)181231(10)H1136644; b) H1139640, Exp 12/31/18, UDI (01)00884450305850(17)181231(10)H1139640
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2017

Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

Complain due to the hub needle came out when the nurse draw the blood and removed the tube.

ALL 50 STATES
Full report

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

Recall #:
80547
Lot/product code:
Serial # 102030178 / Lot # 160815
Recalling firm:
Guangzhou Improve Medical Instruments Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2017

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

ALL 50 STATES
Full report

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

Recall #:
78225
Lot/product code:
c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351
Recalling firm:
Abbott Laboratories, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2017

Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

ALL 50 STATES
Full report

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

Recall #:
78225
Lot/product code:
Serial numbers - 125589-1-2, 125589-1-4
Recalling firm:
Abbott Laboratories, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 16, 2017

Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup).

ALL 50 STATES
Full report

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

Recall #:
78441
Lot/product code:
all DS-8100 units manufactured and distributed worldwide.
Recalling firm:
Fukuda Denshi Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodUndeclaredRecalled October 19, 2017

bliss anti-stress formula Dietary Supplement, 60 Tablets; Manufactured For and distributed by: Market America, Inc., 1302 Pleasant Ridge Road, Greensboro, NC 27409; UPC 8 48570 00470 3

Potentially not listed on the label Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy.

Full report

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

Recall #:
F-0681-2020
Lot/product code:
Lot #: 51130, Expiration Date: 07/2019 Manufacturer's Code PK-MA13173 Manufacturer's Item #Z02320
Recalling firm:
Market America Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2017

VariCam

A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.

ALL 50 STATES
Full report

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

Recall #:
81736
Lot/product code:
Serial Numbers: 0000000010-203 0000000010-191 000003100-1829 00008125-18-18 00000000010-15 00000000010-63 00008125-16-59 000000099-4-04 00000000010-31 00000000010-82 00008125-16-70 00008125-18-09 00008125-18-16 00000000017-64 10280 00000000010-30 000003681-1803 00000000018-24 000003100-1840 000003101-1502 000003100-1744 00000000017-36 00000000016-86 00000000017-31 1065 1998 1999 000008125-1630 1008 00000000017-20 00000000017-22 00000000017-23 1804 00000000030-14 00000000030-15 00000000010-37 00000000010-44 00000000010-55 00000000030-16 00000000018-39 1704 00000ICPO50612 1697 1696 000000163-1758 00000000018-23 00000000016-73 00000000030-04 00000000010-59 00000000018-22 000003100-1760 000003100-1743 0000000010-134 000003100-1719 343 000003100-1763 61061 00000000010-04 00000000030-11 1649 00000000010-67 00000000010-45 00000000017-27 00000000017-15
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2017

Discover VH/Millennium VG Nuclear Medicine Imaging System

A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.

ALL 50 STATES
Full report

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

Recall #:
81736
Lot/product code:
Serial Numbers: 10191 10571 10269 1078 10340 10541 1081 10237 10326 1538 10171 1039 1080 10316 10177 10156 10197 10539 10395 1058 1372 10189 1107 1132 10438 10359 10406 10547 10375 10534 10182 3874990 10139 10555 1141 10354 10338 1056 10481 1035 10210 10572 10281 10190 10179 10193 1016 10300 10501 10284 10446 1119 10146 1100 10178 10041 00000011278NU9 3003 1126 10235 1013 10263 10526 10488 10507 10165 36478041 10239 10398 1025 10143 10390 10260 10435 10422 10445 10222 10357 10218 1046 10491 10353 10180 10530 5004 10256 10288 10333 10516 10556 10379 UNKASM00109201 10462 10557 10195 10581 10468 10560 10463 1890 10417 10334 DUMFMI40849011 10323 10425 10270 10426 1101 10453 10343 10348 10533 10412 10405 10494 DUMFMI40849005 10414 10561 10553 10461 10103 10352 10346 10529 1123 10213 10248 10371 10474 10023 1069 10385 1835 1118 1831 10362 10387 10393 10366 10466 10579 10585 10605 1003 1006 1038 1027 10057 1091 1060 1073 1102 1106 10180 10187 10236 1116 10242 10292 10238 10241 10336 10389 10373 10467 10504 10525 10593 10586 10447 10603 10597 10563 10408 10386 10436 10479 10477 1112 10543 10545 10538 10596 10537 1085 1153 10399 1095 1149 1105 1145 10230 10552 10265 10416 10575 10521 10185 DUMFMI40849014 10567 10480 10433 1814 10312 10167 UNKASM00109204 40772394 10212 10508 10188 10364 10294 10279 10587 10582 UNKASM00109200 10282 10485 10457 10355 DUMFMI40849009 1076 10505 10431 10495 10600 10253 10320 10345 1144 10559 10527 10325 DUMFMI40849019 10360 10396 10606 10514 10522 10268 10206 10564 10328 10456 10486 10489 10342 10562 10589 10520 10368 10424 10434 10448 10240 10402 10487 10249 10403 10428 10531 10313 10397 10598 10450 10591 10483 1155 10303 10519 10550 10439 10363 10599 10548 10314 10297 10401 10250 10401 10121 10400 10540 10207 10194 10476 10584 10204 10595 10594 10570 10040 1289 10175 10164 10384 1010 1072 10146 10133 10449 10283 10410 10169 10276 1066 10209 10376 10381 10244 1756 10420 10332 10216 10454 10124 10158 0000D4360X4372 10374 10378 1021 1074 1042 10518 10224 10590 DUMFMI40849016 10475 10493 10339 10172 10568 10028 10392 10302 10576 10291 10174 10569
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2017

Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939293052030 (Material Description Innova 5 x 200 x 130); b. H74939293052070 (Material Description Innova 5 x 200 x 75); c. H74939293062030 (Material Description Innova 6 x 200 x 130); d. H74939293062070 (Material Description Innova 6 x 200 x 75); e. H74939293072030 (Material Description Innova 7 x 200 x 130); f. H74939293072070 (Material Description Innova 7 x 200 x 75); g. H74939293082030 (Material Description Innova 8 x 200 x 130); h. H74939293082070 (Material Description Innova 8 x 200 x 75)

Stent possibly unable to be fully released from the delivery system.

ALL 50 STATES
Full report

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

Recall #:
78587
Lot/product code:
a. Innova 5 x 200 x 130 (Batch No. 18095733, 18137885, 18233108, 18379812, 18362996, 18420576, 18404859, 18457350, 18478823, 18488703, 18519986, 18696468, 18670333, 18667082, 18756979, 18855752, 18844729, 18872178, 18886680, 18866631, 18892405, 18900294, 18951278, 19039704, 19064055, 19079251, 19111601, 19173251, 19206070, 19238815, 19231426, 19351863, 19309202, 19382422, 19367647, 19426956, 19483869, 19490837, 19501322, 19540549, 19540559, 19569664, 19641827, 19750808, 19742326, 19830060, 19844547, 19873365, 19907333, 19970577, 20014162, 20080095, 20096498, 20112175, 20186872, 20223208, 20216043, 20435880, 20151952, 20444934, 20439618, 20314154, 20336209, 20394072, 20608020, 20608137, 20607734, 20657170, 20420612, 20337854, 20450027, 20616298, 20777472, 20470018, 20672513, 20832034, 20876897, 20871401, 20728970, 20776633, 20851808, 20975844, 21020806, 21124105, 21045072, 21057925, 21091417, 21115593);  b. Innova 5 x 200 x 75 (Batch No. 18343796, 18115802, 18379813, 19013283, 21124110);  c. Innova 6 x 200 x 130 (Batch No. 18152540, 18137923, 18096697, 18119044, 18119040, 18115810, 18230863, 18108301, 18230864, 18211280, 18211281, 18245462, 18230637, 18230636, 18410450, 18428643, 18473268, 18283383, 18343799, 18439907, 18431333, 18368130, 18523235, 18519980, 18661526, 18488709, 18389662, 18498563, 18515152, 18446693, 18733063, 18759192, 18759189, 18766678, 19540741, 18791863, 18832544, 18792872, 18855754, 18860236, 18823216, 18866636, 18844738, 18892194, 18900365, 18870948, 18872541, 18878446, 18900381, 18888435, 18988348, 18961203, 19064043, 18945808, 19072771, 19111551, 19079253, 19151922, 19116475, 19164618, 19206072, 19226126, 19141574, 19245284, 19240145, 19288826, 19288832, 19309205, 19309206, 19367648, 19377502, 19408962, 19426948, 19389007, 19490838, 19511466, 19501332, 19517646, 19545788, 19555598, 19560848, 19569663, 19589370, 19584757, 19641826, 19635253, 19664685, 19654162, 19670616, 19709446, 19728413, 19699320, 19782868, 19693686, 19682956, 19682955, 19830064, 19873362, 19907334, 19905446, 19941738, 19942503, 19918783, 20013959, 19970579, 20014164, 20023939, 20109861, 20188996, 20080098, 20080097, 20188052, 20187538, 20080096, 20109863, 20112179, 20320562, 20830984, 20216045, 20183756, 20158213, 20433364, 20434473, 20233669, 20286988, 20233670, 20303729, 20342627, 20233668, 20607288, 20574727, 20607402, 20455108, 20368051, 20432603, 20511193, 20394775, 20594724, 20635843, 20776979, 20478648, 20821884, 20754076, 20758252, 20821886, 20800469, 20886809, 20825353, 20885852, 20938124, 20913156, 20950528, 20975845, 20997424, 21004412, 21119055, 21117395, 21058225, 21098042, 21071017, 21122202, 21145025, 21145024, 21219047, 21219242, 21219052);  d. Innova 6 x 200 x 75 (Batch No. 18389661, 18623249, 18870949, 18900366, 19161485, 19245285, 19918786, 20635844, 20862432, 21098043);  e. Innova 7 x 200 x 130 (Batch No. 18152541, 18099223, 18130828, 18113523, 18230638, 18217571, 18211282, 18186723, 18240225, 18168041, 18291418, 18339045, 18368242, 18283384, 18339044, 18316737, 18394605, 18385509, 18420569, 18313150, 18488713, 18921110, 18961213, 19072776, 19134318, 19173258, 19161488, 19206078, 19228862, 19255680, 19288830, 19309211, 19377507, 19327253, 19408970, 19436702, 19483875, 19491821, 19501423, 19527344, 19555961, 19545789, 19624864, 19659433, 19693528, 19670619, 19709445, 19830069, 19811429, 19742336, 19918785, 19907336, 19851529, 19974524, 19974523, 20080094, 20001802, 20109860, 20001803, 20188364, 20109862, 20177945, 20181650, 20210393, 20244728, 20321275, 20320380, 20286989, 20434033, 20267930, 20405389, 20381126, 20316570, 20574731, 20607286, 20352590, 20442151, 20466869, 20622461, 20655052, 20495971, 20518171, 20628127, 20777268, 20777261, 20820730, 20731022, 20833824, 20758256, 20886953, 20819295, 20856506, 20910181, 20937554, 21004415, 21119514, 20997428, 21119515, 21045505, 21103020, 21058247, 21138682, 21217652);  f. Innova 7 x 200 x 75 (Batch No. 18336507, 18598712, 18733075, 18802238, 18892409, 18999955, 19151414, 19245286, 19511477, 19569668, 19684652, 19811430, 20699739, 20729796, 20978808, 21122996);  g. Innova 8 x 200 x 130 (Batch No. 18211294, 18313156, 18385119, 18519981, 18583365, 18611781, 18733076, 18754584, 18780335, 18844724, 18977671, 19006855, 19048092, 19072779, 19188060, 19245289, 19304348, 19351866, 19454525, 19501424, 19624788, 19664694, 19684647, 19839023, 19782933, 20014160, 20080099, 20112342, 20216047, 20286991, 20439603, 20386608, 20655679, 20655677, 20329707, 20410534, 20655798, 20357647, 20997431, 21123358, 21123667);  h. Innova 8 x 200 x 75 (Batch No. 18115809, 18313157, 18877978, 19161490, 19624794, 19887625, 20410535, 20862411)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2017

Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939180051870 (Material Description Innova-EU 5 x 180 x 75); b. H74939180061870 (Material Description Innova-EU 6 x 180 x 75); c. H74939180071870 (Material Description Innova-EU 7 x 180 x 75); d. H74939180071870 (Material Description Innova-EU 8 x 180 x 75); e. H74939181051830 (Material Description Innova-EU 5 x 180 x 130); f. H74939181061830 (Material Description Innova-EU 6 x 180 x 130); g. H74939181071830 (Material Description Innova-EU 7 x 180 x 130); h. H74939181081830 (Material Description Innova-EU 8 x 180 x 130); i. H74939259051830 (Material Description Innova-China 5 x 180 x 130); j. H74939259061830 (Material Description Innova-China 6 x 180 x 130); k. H74939259071830 (Material Description Innova-China 7 x 180 x 130); l. H74939259081830 (Material Description Innova-China 8 x 180 x 130); m. H74939259081870 (Material Description Innova-China 8 x 180 x 75); n.H74939293051830 (Material Description Innova 5 x 180 x 130); o. H74939293051870 (Material Description Innova 5 x 180 x 75); p. H74939293061830 (Material Description Innova 6 x 180 x 130); q. H74939293061870 (Material Description Innova 6 x 180 x 75); r. H74939293071830 (Material Description Innova 7 x 180 x 130); s. H74939293071870 (Material Description Innova 7 x 180 x 75); t. H74939293081830 (Material Description Innova 8 x 180 x 130); u. H74939293081870 (Material Description Innova 8 x 180 x 75);

Stent possibly unable to be fully released from the delivery system.

ALL 50 STATES
Full report

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

Recall #:
78587
Lot/product code:
a. Innova-EU 5 x 180 x 75 (Batch No. 17520924 18202150 18759183 19079259 19699151 19699152 19699153 19699154 19741583 19750952 19856648 19858137 20818430);  b. Innova-EU 6 x 180 x 75 (Batch No. 17620115 17692708 17855043 18018503 18061521 18074203 18202155 18255925 18353496 18412277 18478379 18751462 18920645 18931139 19021594 19342056 19394346 19426941 19644666 19741582 19946632 20197319 20495963 20818433 21239460 );  c. Innova-EU 7 x 180 x 75 (Batch No. 17612617 17832625 18082136 18394610 19750817 20314145);  d. Innova-EU 8 x 180 x 75 (Batch No. 17520931 18628352 20818435);  e. Innova-EU 5 x 180 x 130 (Batch No. 17379136 17515253 17643398 17796883 17884790 17928403 17999422 18028550 18065189 18193713 18242545 18320365 18412270 18505175 18572704 18754507 18924413 18937020 18945803 19048201 19129188 19264799 19406217 19469659 19654093 19728059 19770174 19858438 19907842 20042126 20109694 20127894 20205065 20260073 20313036 20405381 20427160 20482532 20557178 20642269 20788044 20980789 21091410 21153699 21239470);  f. Innova-EU 6 x 180 x 130 (Batch No. 17339472 17360205 17393388 17507373 17563587 17567306 17621181 17643722 17692709 17751231 17775135 17837622 17893341 17918022 17951215 17977931 18006854 18028547 18065191 18242554 18305612 18412278 18488248 18523620 18688894 18708475 18751464 18802815 18838475 18920656 18999958 19105369 19129190 19178742 19222890 19317120 19367656 19406219 19491632 19597808 19644663 19654080 19664965 19780796 19786768 19815613 19851783 19946633 19984995 20042120 20100778 20127896 20186867 20193387 20260077 20297197 20316561 20378797 20427172 20466862 20478643 20646353 20754062 20797639 20862259 20913445 20980791 21004779 21032769 21178771 21216860 21239475 21276391);  g. Innova-EU 7 x 180 x 130 (Batch No. 17351561 17422684 17524012 17662465 17832627 17860677 17916569 17959306 18010628 18028548 18242534 18242556 18320373 18412269 18530138 18592948 18682281 18708601 18785731 18838474 18923775 19021789 19079547 19129191 19178744 19212926 19238403 19317121 19394343 19465187 19693682 19750818 19844551 19907848 20013943 20089474 20199942 20303720 20316576 20413225 20597205 20616293 20685727 20793173 20913448 21096958 21135270 21216475 21250891);  h. Innova-EU 8 x 180 x 130 (Batch No. 17349971 17360218 17672512 17951214 18065192 18074216 18320379 19129192 19299435 19635495 19728402 19775531 19946636 20109698 20171185 20495967 20646355 20793176 20818437 21075729 21163790 21240950);  i. Innova-China 5 x 180 x 130 (Batch No. 17456003 17456004 17629285 17851466 18077817 18899799 19048094 19474494 19511479 20455112 20539787 20562445 20754066 21045500 21121559 21271047);  j. Innova-China 6 x 180 x 130 (Batch No. 17454410 17454411 17454412 17456007 17542769 17629280 17727197 17851471 17988287 19169697 19291890 19327248 20936472 21020803);  k. Innova-China 7 x 180 x 130 (Batch No. 17456009 17456010 17463352 17727483 19354376);  l. Innova-China 8 x 180 x 130 (Batch No. 17456013 17823505 21130830);  m. Innova-China 8 x 180 x 75 (Batch No. 19491836);  n. Innova 5 x 180 x 130 (Batch No. 18558414);  o. Innova 5 x 180 x 75 (Batch No. 18583366 18611575 18754514);  p. Innova 6 x 180 x 130 (Batch No. 18565240 18583363 18644031 18733070 18741089 18744848 18754518 18771910 18780329 18797248 18813744 18823218 18850635 18872987 18886683 18892198 18900363 18913810 18977667 18988346 19013254 19039706 19116474 19129194 19141572 19151411 19164783 19185695 19185696 19188063 19188064 19199363 19212932 19212933 19222885 19240144 19240152 19252774 19267183 19267184 19288822 19288823 19288824 19399366 19464898 19475060 19501338 19511461 19527257 19540740 19545787 19560851 19589364 19609498 19664968 19752067 20109864 20112178 20159642 20186873 20216044 20233666 20247011 20279930 20370769 20394773 20529709 20594722 20602686 20611981 20627806 20628410 20642280 20800467 21098041 21122201 21239472 21239478);  q. Innova 6 x 180 x 75 (Batch No. 18563662 18611780 18632059 18733071 18741090 18744849 18751309 18759188 18832543 18839009 18844736 18860228 18866635 18872988 18900364 18913805 18913815 18977668 18988347 19013255 19039707 19048089 19141573 19151412 19173253 19199364 19240153 19262043 19288825 19294325 19309204 19338270 19372772 19399367 19426947 19438864 19500739 19511465 19540552 20159643 20233667 20394774 20430591 20485381 20594723 20611982 20754075 20800468 21244560);  r. Innova 7 x 180 x 130 (Batch No. 18558405 18583034 18587957 18620266 18670462 18696465 18713419 18733074 18754519 18785736 18791864 18823243 18886686 18888437 18913807 18920778 18935052 18977677 19006945 19013288 19129197 19139329 19149499 19164785 19173248 19185690 19206077 19228860 19272466 19288833 19309209 19382430 19408968 19408969 19426954 19426955 19464890 19500738 19527254 19597803 19644373 20109866 20138146 20186874 20216046 20244727 20267929 20292468 20611983 20611984 21098798 21135264 21240956);  s. Innova 7 x 180 x 75 (Batch No. 18550162 18563667 18604196 18632052 18661523 18670463 18696466 18713940 18741084 1875… (truncated, 5497 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 10, 2017

Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

Internal program testing shows that product may not reach the indicated expiration date.

ALL 50 STATES
Full report

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

Recall #:
79181
Lot/product code:
Product Code 1293254, Lot Code 1709228140
Recalling firm:
Wiener Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2017

Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.

The recalled lots have demonstrated unexpected false positive THC results.

ALL 50 STATES
Full report

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

Recall #:
78608
Lot/product code:
Lots 403111, 406741, 396588, 398577, 396587
Recalling firm:
Alere San Diego, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2017

Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.

Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.

ALL 50 STATES
Full report

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

Recall #:
78885
Lot/product code:
Serial Numbers:  152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342
Recalling firm:
Carl Zeiss Metrology Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 20, 2017

Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.

While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.

ALL 50 STATES
Full report

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

Recall #:
80057
Lot/product code:
MODEL #(s):  453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375,  US1203010398, US1203010407, US1304000043, US1304000046,  US1224000050, US1550001470, US1251000063, US1109010070,  US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396,  US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478,  US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005,  US1231000060, US1537001268, US1537001272, US1537001276, US1537001277, US1537001280, US1537001338, US1202010174,  US1417000023, US1419000042, US1412000038, US1419000004,  US1419000023, US1419000052, US1424000010, US1424000018, US1431000027, US1239000034, US1550001491, US1338000001,  US1550001502, US1550001468, US1611001807, US1611001814,  US1611001826, US1611001831, US1611001850, US1248000004,  US1248000025, US1248000028, US1248000035, US1517000665,  US1517000671, US1517000680, US1443000225, US1724000551,  US1724000561, US1729000573, US1729000601, US1729000604,  US1311000065, US1407000058, US1334000037, US1224000027,  US1304000017, US1517000691, US1517000696, US1352000036, US1652000003, US1652000011, US1652000016, US1652000042, US1505000498, US1505000518, US1505000567, US1337000007, US1337000008, US1343000057, US1352000052, US1203010408,  US1511000639, US1534001157, US1534001158, US1534001163, US1534001165, US1534001167, US1534001171, US1534001220,  US1534001223, US1534001226, US1534001229, US1534001230,  US1534001232, 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US1343000089, US1611001820, US16110018… (truncated, 14887 characters total — see the official FDA record for the full value)
Recalling firm:
Invivo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2017

CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells

A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.

ALL 50 STATES
Full report

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

Recall #:
80137
Lot/product code:
Versions 6.0.1 or 6.0.2
Recalling firm:
Cellavision AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE MRI DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L311
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VALITUDE X4 CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U128
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VISIONIST CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U225 and Model 226
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VALITUDE CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U125
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L300
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)