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Recalls affecting Wisconsin

Data last updated: September 9, 2026 at 1:18 PM UTC

16,927 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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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)
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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Kid Gluten Free Fruit & Oat Bar Organic Blueberry & Raspberry. SKU: KB-BLRB-5. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.99 oz(28g) and packed in 5 pack box (Net Wt. 4.95 OZ (140g). UPC code: 819573014389.

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Full report

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

Recall #:
F-0069-2021
Lot/product code:
BB 14 APR 2021 20105 BB 05 MAY 2021 20126 BB 11 MAY 2021 20132 BB 01 JUN 2021 20153 BB 08 JUL 2021 20190 BB 13 JUL 2021 20195 BB 04 AUG 2021 20217
Recalling firm:
Nurture Inc. dba Happy Family
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas, Strawberries, & Sunflower Butter. SKU: TB-BASTSB-5 and TB-BASTSB-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 819573015089.

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Full report

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

Recall #:
F-0068-2021
Lot/product code:
BB 13 APR 2021 20104 BB 08 MAY 2021 20129 BB 20 MAY 2021 20141 BB 21 MAY 2021 20142 BB 08 JUN 2021 20160 BB 09 JUN 2021 20161 BB 15 JUN 2021 20167
Recalling firm:
Nurture Inc. dba Happy Family
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 16, 2020

Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIEC 980X3ITDIEC 980X3JADIJJ 980X3SVAIQC 980U3ENASAA 980U1ENDICU 980U1FRDICU 980X3ENDRAC 980X1FRDISS 980A3ENNISB 980X1PLDIPC 980X3SKNISC 980U3ESDIUU 980X1DEDISS 980X3DEDISS 980X3HUNISC 980X3ENDIPP 980X1BGDRAC 980X1ENDRAC 980X1NLDRAC 980A1ENNISB 980X3TRDRAC 980X3CSNISC 980U3ESDIUC 980U1ENASAA 980X1JADIJJ 980X1FRAIQC 980X1ENDIPC 980X1ENNISB 980X1ESDIEC 980X1ITDIEC 980X1PTDIPC 980X1DEDRAC 980X1TRDRAC 980X3RODRAC 980S1ENDICU 980X3RUDRAC 980U1ESDIUU 980U3ESDIUA 980X3SRDRAC 980X1ENDIPP 980U1ESDIUC 980X3ENDIUU 980X3ENDIJI 980X1SKNISC 980X3PTDIPC 980U1ESDIUA 980U3PTDIUNA 980X1DAAGAC 980X1FIAGAC 980X1NOAGAC 980X1SVAGAC 980X3ENAIQC 980X1HUNISC 980X2ENDIUU 980X3ENASAA 980X1ENASAA 980S3ESDIUU 980X1RODRAC 980S1PTDIUNA 980X1SLDRAC 980S1ESDIUU 980S1ESDIUC 980S3ESDIUA 980S1ESDIUA 980S3ESDIUC 980S1FRDICU 980S3ENDICU 980X2ENASAA 980X2ITDIEC 980X1ELAIQC 980X2DEDRAC 980X2FRAIQC 980X2ENNISB 980X2ESDIEC 980A2ENNISB 980X2PLDIPC 980X1ENAIQC 980U1PTDIUNA 980X3ENDISS 980X2ENDISS 980X1HRDRAC 980X3RUDIEC 980U3ENDICU 980X1SRDRAC 980X1ENDIJI 980X2RUDRAC 980X3ENDIPB 980P1ZHNISD 980P3ZHNISD 980C1ZHNISD 980C3ZHNISD 980C2ZHNISD 980N1ZHNISD 980N3ZHNISD 980P2ZHNISD 980X1ENNISC 980U3ENDIUU-LA 980U1ENDIUU-LA

In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

ALL 50 STATES
Full report

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

Recall #:
86643
Lot/product code:
serial 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35B1400342 35B1400330 35B1400345 35B1400346 35B1400350 35B1400355 35B1400359 35B1400367 35B1400373 35B1400321 35B1400308 35B1400244 35B1400329 35B1400354 35B1400371 35B1400314 35B1400319 35B1400344 35B1400348 35B1400365 35B1400369 35B1400375 35B1400377 35B1400378 35B1400349 35B1400364 35B1400370 35B1400347 35B1400368 35B1400383 35B1400331 35B1400372 35B1400356 35B1400382 35B1400299 35B1400385 35B1400388 35B1400263 35B1400396 35B1400400 35B1400339 35B1400357 35B1400337 35B1400384 35B1400392 35B1400401 35B1400335 35B1400407 35B1400393 35B1400395 35B1400404 35B1400411 35B1400376 35B1400408 35B1400389 35B1400390 35B1400410 35B1400413 35B1400387 35B1400386 35B1400353 35B1400415 35B1400417 35B1400421 35B1400358 35B1400397 35B1400405 35B1400419 35B1400426 35B1400428 35B1400435 35B1400399 35B1400439 35B1400442 35B1400257 35B1400361 35B1400402 35B1400423 35B1400431 35B1400444 35B1400446 35B1400445 35B1400449 35B1400452 35B1400457 35B1400458 35B1400466 35B1400434 35B1400409 35B1400425 35B1400448 35B1400455 35B1400144 35B1400236 35B1400300 35B1400379 35B1400437 35B1400438 35B1400468 35B1400472 35B1400482 35B1400486 35B1400489 35B1400490 35B1400491 35B1400492 35B1400493 35B1400495 35B1400496 35B1400499 35B1400500 35B1400501 35B1400502 35B1400505 35B1400506 35B1400507 35B1400094 35B1400128 35B1400459 35B1400414 35B1400454 3… (truncated, 274432 characters total — see the official FDA record for the full value)
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 16, 2020

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

ALL 50 STATES
Full report

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

Recall #:
86669
Lot/product code:
Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577
Recalling firm:
Ortho Clinical Diagnostics Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 23, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

ALL 50 STATES
Full report

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

Recall #:
D-0068-2021
Lot/product code:
MET100201, MET100401 EXP 05/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 23, 2020

Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.

ALL 50 STATES
Full report

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

Recall #:
86700
Lot/product code:
(01) 00848486030193 (21), Serial numbers: 4200052, 4200095, 4200112, 4200117, 4200119, 4200167, 4200190, 4200193, 4200202, 4200203, 4200204, 4200226, 4200233, 4200235, 4200248, 4200250, 4200257, 4200269, 4200270, 4200288, 4200293, 4200305, 4200350, 4200373, 4200384, 4200387, 4200391, 4200397, 4200398, 4200400, 4200409, 4200436, 4200457, 4200459, 4200477, 4200488, 4200512, 4200540, 4200548, 4200550, 4200558, 4200624, 4200645, 4200653, 4200666, 4200717, 4200766, 4200774, 4200785, 4200789, 4200801, 4200806, 4200807, 4200816, 4200843, 4200856, 4200868, 4200904, 4200917, 4201000, 4201040, 4201068, 4201089, 4201102, 4201103, 4201121, 4201167, 4201218, 4201236, 4201238, 4201253, 4201296, 4201302, 4201366, 4201367, 4201376, 4201385, 4201408, 4201412, 4201442, 4201452, 4201454, 4201477, 4201490, 4201630, 4201661, 4201714, 4201752, 4201829, 4201831, 4201851, 4202009, 4202020, 4202038, 4202044, 4202062, 4202063, 4202122, 4202146, 4202162, 4202175, 4202315, 4202333, 4202626, 4202631, 4202659, 4202729, 4202742, 4202882, 4202987, 4203180, 4203198, 4203289, 4203424, 4203441, 4203649, 4203709, 4203728, 4203730, 4203731, 4203736, 4203807, 4203826, 4204015, 4204164, 4204389, 4204448, 4204539, 4204553, 4204577, 4204673, 4204812, 4204934, 4205093, 4205190, 4205380, 4205426, 4206219, 4206271, 4209023, 4209025, 4209044, 4209045, 4209046, 4209065, 4209066, 4209067, 4209068, 4209071, 4209149, 4209151, 4209155, 4209156, 4209157, 4209162, 4209164, 4209166, 4209167, 4209171, 4209185, 4209189, 4209210, 4209211, 4209213, 4209220, 4209244, 4209250, 4209252, 4209255, 4209256, 4209259, 4209261, 4209262, 4209267, 4209268, 4209271, 4209298, 4209299, 4209303, 4209304, 4209306, 4209308, 4209312, 4209317, 4209318, 4209345, 4209346, 4209357, 4209360, 4209363, 4209364, 4209365, 4209387, 4209388, 4209389, 4209398, 4209441, 4209443, 4209460, 4209463, 4209464, 4209466, 4209471, 4209472, 4209473, 4209474, 4209475, 4209476, 4209477, 4209486, 4209487, 4209491, 4209493, 4209494, 4209495, 4209496, 4209500, 4209519, 4209522, 4209526, 4209529, 4209531, 4209532, 4209533, 4209535, 4209541, 4209542, 4209543, 4209546, 4209597, 4209598, 4209599, 4209600, 4209601, 4209602, 4209604, 4209605, 4209606, 4209607, 4209608, 4209609, 4209610, 4209611, 4209612, 4209613, 4209614, 4209615, 4209616, 4209621, 4209628, 4209632, 4209634, 4209635, 4209637, 4209639, 4209640, 4209647, 4209667, 4209671, 4209685, 4209694, 4209698, 4209734, 4209764, 4209771, 4209774, 4209775, 4209776, 4209777, 4209778, 4209779, 4209780, 4209781, 4209782, 4209783, 4209784, 4209785, 4209786, 4209787, 4209788, 4209789, 4209790, 4209791, 4209792, 4209793, 4209794, 4209795, 4209796, 4209797, 4209798, 4209799, 4209800, 4209801, 4209802, 4209803, 4209804, 4209805, 4209806, 4209807, 4209808, 4209809, 4209810, 4209811, 4209812, 4209813, 4209814, 4209815, 4209816, 4209817, 4209818, 4209819, 4209820, 4209821, 4209822, 4209823, 4209834, 4209849, 4209859, 4209860, 4209863, 4209927, 4209928, 4209929, 4209930, 4209931, 4209932, 4209933, 4209934, 4209935, 4209936, 4209937, 4209938, 4209939, 4209940, 4209941, 4209942, 4209943, 4209945, 4209946, 4209947, 4209948, 4209949, 4209950, 4209951, 4209952, 4209954, 4209955, 4209956, 4209957, 4209959, 4209960, 4209961, 4209962, 4209963, 4209964, 4209965, 4209966, 4209967, 4209968, 4209969, 4209985, 4209986, 4209987, 4209988  Updated information submitted: Serial numbers removed from 12/23/20 letter: 4200112, 4200117, 4200202, 4201412, 4201490, 4201661; reason: These devices are still in scope and exhibit the issue. However, it was found that none of these devices were distributed to a customer. Therefore, they were removed from the attachment in the letter and are within Stryker control.  Serial Numbers added to the recall letter: 4209292, 4209646, 4209841, 4202629, 4203963; reason: These devices were originally thought to be in Stryker control, but were shipped to customers.   Serial Numbers added to the recall letter: 4209917, 4209922, 4209924; reason: These devices were shipped to Stryker OUS distributor and were thought to be distributed to customers. (Firm later confirmed that the units are under Stryker control.)
Recalling firm:
Mako Surgical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 23, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

ALL 50 STATES
Full report

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

Recall #:
D-0067-2021
Lot/product code:
MET200101, MET200301 EXP 05/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled October 27, 2020

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

ALL 50 STATES
Full report

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

Recall #:
D-0103-2021
Lot/product code:
Lot #: a) C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022; C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN, Exp 7/31/2022; C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS, Exp 8/31/2022; C240GM, C240GP, C240GQ, C240GR, Exp 9/30/2022; b) C191KR, Exp 7/31/2020
Recalling firm:
Sunstar Americas, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2020

6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

ALL 50 STATES
Full report

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

Recall #:
86699
Lot/product code:
Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)
Recalling firm:
Chromsystems Instruments & Chemicals GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2020

MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

ALL 50 STATES
Full report

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

Recall #:
86699
Lot/product code:
Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
Recalling firm:
Chromsystems Instruments & Chemicals GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2020

MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

ALL 50 STATES
Full report

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

Recall #:
86699
Lot/product code:
Order No. 0350, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
Recalling firm:
Chromsystems Instruments & Chemicals GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
041520022A, 061920022A, and 081120022A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A, 032420024A, 032620024A, 033120024A, 040220024A, 040320024A, 040420024A, 040620024A, 040720024A, 040920024A, 041120024A, 041420024A, 041620024A, 041820024A, 042020024A, 042120024A, 042320024A, 042520024A, 060320024A, 061320024A, 062320024A, 070820024A, 071020024A, 072120024A, 072920024A, 080720024A, 081920024A and 091120024A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
050620026A and 072120026B,
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Plus Part Number: 1137276 V60 Plus Ventilator, International  Serial Numbers: 100341890 100341897 100343602 100343674 100345138 100345145 100345148 100352752 100352754 100354448 100354454 100354464 100354470 100354838 100354875 100357792 100358141 100358158 100358355 100359515 100381237 100381430 100381436 100381765 100381835 100381850 100384222 100384818 100384821 100384875 100384878 100384903 100387138 100387261 100387407 100387412 100387557 100387860 100387941 100387953 100388063 100388068 100388092 100388630 100388634 100388640 100388641 100388649 100388676 201040204 201040216 100345306 100345307 100346866 100346876 100346889 100346894 100346895 100346896 100346898 100346901 100346907 100346908 100346909 100346910 100346911 100346913 100348081 100348085 100348140 100348146 100352062 100355386 100355900 100355923 100356012 100356258 100356302 100356303 100360343 100360364 100360378 100361206 100361563 100361576 100362006 100362051 100364563 100369571 100369619 100369692 100369705 100369912 100375136 100375594 100375911 100375912 100378897 100378926 100378928 100378931 100378932 100378934 100378937 100297858 100298767 100298799 100298928 100298929 100300520 100302008 100302012 100304689 100304697 100304701 100305136 100305821 100306638 100309643 100310997 100311467 100311473 100311480 100314877 100320637 100327540 100327543 100327548 100336899 100337246 100346856 100346858 100348113 100348114 100348445 100350151 100350153 100352753 100352806 100352809 100352829 100354067 100354070 100354076 100354458 100354867 100355162 100355880 100355911 100355917 100355920 100356279 100358146 100359620 100359623 100360200 100361432 100361971 100362036 100362065 100362515 100362567 100362728 100363719 100363755 100363759 100363798 100364540 100365111 100365141 100365653 100367161 100368606 100371204 100371644 100376389 100378064 100378069 100378077 100378215 100378278 100378301 100378302 100378305 100378538 100378665 100378679 100378680 100378681 100378686 100378993 100379006 100380659 100380822 100380929 100380930 100380964 100380995 100381265 100381726 100381768 100381822 100381823 100381826 100381829 100381830 100381832 100381840 100381841 100381843 100381844 100381845 100381848 100381856 100381901 100381906 100381908 100381911 100381912 100381923 100381924 100381928 100381930 100382181 100382190 100384081 100385057 100385165 100385304 100385305 100388680 201040139 201040199 201040202 201040206 201040208 201040210 201040213 201040214 201040311 201040314 201040327 100342965 100343117 100345137 100345591 100345624 100346213 100346218 100346249 100346261 201038743 100381339 100381905 100383913 100384289 100384873 100385163 100390089 100297860 100357138 100298655 100298659 100321724 100321729 100321905 100322861 100322870 100322890 100322896 100322897 100322901 100322902 100353273 100355396 100355670 100355878 100355890 100355895 100355926 100357131 100357731 100357749 100357770 100358145 100358148 100358312 100358341 100348173 100348175 100348176 100348178 100348440 100351489 100351490 100351495 100351497 100351546 100351553 100359604 100359767 100359949 100289710 100290611 100290612 100290642 100290646 100309491 100309492 100309578 100309641 100309646 100309733 100309736 100309738 100309820 100309823 100318609 100318616 100320638 100321702 100321714 100321720 100321796 100322865 100322879 100322884 100322886 100322887 100325103 100325104 100325108 100325117 100325118 100325260 100341866 100341896 100341904 100341908 100341997 100342528 100342896 100342956 100343113 100343120 100343151 100343158 100343162 100343524 100343544 100343568 100343622 100343700 100344208 100344215 100344219 100344370 100344662 100344668 100344670 100344677 100344679 100344680 100344685 100344686 100344689 100344690 100344969 100344970 100344972 100344973 100344975 100345116 100345122 100345140 100345142 100345143 100345144 100345146 100345147 100345151 100345153 100345154 100345303 100345308 100345312 100345339 100345342 100345345 100345518 100345564 100345566 100345570 100345571 100345573 100345581 100345583 100345608 100346257 100346275 100346277 100346297 100346300 100346302 100346304 100346309 100346318 100346321 100346328 100346330 100346331 100346853 100346875 100348128 100348131 100348145 100348147 100348443 100350134 100350663 100350677 100350712 100350715 100350723 100350725 100350935 100351349 100351350 100351356 100351487 100351492 100351496 100351563 100351564 100351570 100351573 100351577 100351581 100351585 100351707 100351709 100351711 100351713 100351715 100351716 100351718 100351719 100351723 100351730 100351732 100351733 100351858 100352040 100352041 100352043 100352046 100352047 100352048 100352049 100352050 100352051 100352052 100352057 100352061 100352066 100352072 100352074 100352075 100352076 100352077 100352078 100352087 100352091 100352092 100352094 100352102 100352105 100352109 100352111 100352116 100352120 100352121 100352747 100352756 100352758 100352803 100352815 100352816 100353242 100353245 100353274 1… (truncated, 38498 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: DU1053617 V60 Ventilator, US Demo Units Serial Numbers: 100002908 100002911 100002913 100002914 100002916 100002959 100003001 100003003 100003005 100003007 100003018 100003046 100003052 100003081 100003674 100003675 100003685 100003689 100003728 100003736 100003757 100003909 100003910 100003913 100003916 100003918 100003919 100004032 100004033 100004077 100004081 100004120 100004122 100004123 100004124 100004125 100004127 100004128 100004131 100004320 100004322 100004323 100004324 100004325 100004508 100004542 100004543 100004545 100004547 100004549 100004550 100004553 100004554 100004555 100004556 100004557 100004558 100004620 100004621 100004622 100004623 100004624 100004625 100004626 100004627 100004982 100004983 100004984 100004985 100004986 100004987 100004988 100004992 100004994 100004995 100004999 100005110 100005116 100005117 100005141 100005147 100005150 100005239 100005241 100005242 100005247 100005251 100005334 100005338 100005347 100005388 100005486 100005489 100005491 100005595 100005690 100005697 100005699 100005987 100006282 100006368 100006884 100006887 100006892 100006893 100006932 100006934 100007044 100007345 100007635 100007712 100008137 100008145 100008148 100008354 100008359 100008422 100008425 100008432 100008644 100008650 100008657 100008854 100008943 100008999 100009000 100009087 100009097 100009098 100009334 100009776 100009856 100009858 100009960 100009973 100010102 100010167 100010202 100010205 100010232 100010518 100011305 100011778 100012044 100012282 100012284 100012290 100012291 100012358 100012542 100012545 100012770 100012896 100012968 100013483 100013600 100013629 100013665 100013666 100013673 100013674 100013675 100015786 100016534 100017356 100024283 100024300 100025783 100025793 100025947 100026813 100026818 100026825 100026948 100027405 100027421 100027744 100029670 100029674 100029677 100029679 100029680 100029682 100029687 100029696 100029698 100029831 100029834 100029836 100029837 100029840 100029841 100029843 100029845 100029846 100029847 100029848 100029851 100029852 100029853 100029854 100029856 100029857 100029860 100030028 100030030 100030033 100030034 100031683 100032466 100032471 100032473 100032474 100032477 100032478 100032479 100032539 100033462 100034676 100034677 100034680 100034691 100034696 100034806 100034807 100034810 100034821 100035425 100035617 100035734 100035745 100035748 100035750 100035751 100035752 100035753 100035757 100035758 100037766 100037774 100037775 100038022 100038420 100038429 100038595 100038597 100038599 100038600 100038608 100038611 100038710 100038712 100038713 100038718 100038719 100038722 100038723 100038725 100038726 100038730 100038733 100039252 100040159 100040163 100040166 100040758 100040848 100040850 100040852 100040854 100040855 100040856 100041393 100041394 100042014 100042015 100042016 100042018 100042019 100042020 100042023 100042024 100042025 100042026 100042027 100042030 100042115 100043383 100043388 100043389 100043390 100043391 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201000055 201000065 201000067 201000078 201000079 201000096 201000097 201000098 201000099 201000100 201000128 201000129 201000130 201000131 201000132 201000133 201000134 201000135 201000145 201000146 201000147 201000148 201000150 201000152 201000153 201000154 201000155 201000156 201000175 201000176 201000196 201000198 201000200 201000201 201000202 201000220 201000297 201000298 201000311 201000312 201000313 201000314 201000315 201000316 201000330 201000331 201000333 201000334 201000337 201000338 201000339 201000340 201000341 201000343 201000380 201000381 201000383 201000384 201000385 201000491 201000494 201000496 201001638 201002012 201002131 201002137 201002138 201002139 201002460 201002461 201002462 201002480 201002556 201002557 201002565 201002571 201002590 201002591 201002597 201002629 201002647 201002651 201002663 201002785 201002802 201002967 201003277 201003279 100031561 Model: V60 Ventilator, Part Number U1053617 V60 Ventilator, USED ENGL OPT:CFLEX, AVAPS,PPV,AT+ Note: U10536… (truncated, 15952 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1053616 V60 Ventilator, English Opt: None Serial Numbers: 100087733 100087738 100087932 100087999 100088155 100004031 100004071 100004073 100005244 100005350 100005351 100005599 100006209 100006210 100006217 100006406 100006701 100006702 100006881 100006883 100006886 100006888 100006891 100006929 100006933 100006939 100006940 100006941 100009417 100009501 100009512 100009513 100009549 100009550 100009553 100009554 100009556 100009566 100009679 100009760 100009761 100009762 100009768 100009769 100009770 100009777 100009812 100009816 100009854 100010206 100010242 100010390 100010514 100010515 100010517 100010519 100011308 100011343 100011344 100011468 100011740 100011741 100011744 100011749 100011750 100011751 100011754 100011791 100011794 100011799 100011801 100011820 100011821 100011822 100011823 100011824 100011825 100011826 100011827 100011828 100011829 100011830 100011831 100012694 100012884 100012887 100012890 100012891 100013021 100013023 100013027 100013032 100013034 100013083 100013667 100013669 100013791 100014073 100014088 100014142 100014147 100014153 100014283 100014286 100015076 100015209 100015213 100015281 100015667 100016078 100016597 100016599 100016736 100016746 100016747 100016749 100017103 100017258 100017287 100017293 100017301 100017302 100019586 100020214 100020215 100020217 100020219 100020220 100020227 100020312 100020314 100020316 100020317 100020445 100020885 100021037 100021042 100021874 100021877 100021968 100023238 100024476 100024484 100025989 100026618 100026620 100026805 100026806 100026807 100026816 100027758 100029842 100029849 100030985 100031674 100033326 100033327 100033328 100033329 100033330 100033332 100033333 100033334 100033335 100033336 100033338 100033339 100033340 100033342 100033454 100034684 100034703 100035358 100035365 100035742 100035744 100035755 100037043 100037044 100037049 100037051 100037057 100037059 100037061 100037257 100038935 100038936 100038939 100040185 100042229 100042475 100043439 100043440 100044800 100044801 100047830 100048873 100049578 100049922 100050003 100050633 100050634 100050638 100050891 100052079 100052289 100052290 100052639 100052645 100053142 100053143 100053337 100053356 100053971 100055007 100056058 100056891 100056894 100058686 100058693 100058698 100063885 100064427 100064431 100064439 100064682 100064684 100064784 100064787 100065219 100066227 100071766 100072295 100079339 100079474 100080118 100080120 100080121 100080122 100080123 100080124 100080126 100080127 100081004 100084640 100091078 100095091 100095180 100095333 100095545 100095633 100095634 100096642 100096690 100096788 100096789 100097541 100097922 100097924 100097926 100097927 100104724 201001172 201001189 201001254 201001255 201001256 201001259 201001260 201001682 201001683 201001696 201001699 201001700 201001720 201001729 201001808 201001812 201001814 201001823 201001825 201001826 201001827 201001829 201001830 201001843 201001849 201001873 201001884 201001939 201001944 201002117 201002148 201002184 201002193 201002426 201002427 201002443 201002445 201002448 201002552 201002566 201002574 201002587 201002770 201002778 201002834 201002868 201002873 201002894 201002899 201002900 201003014 201003145 201003149 201003179 201003183 201003185 201003187 201003216 201003219 201003233 201003238 201003263 201003266 201003268 201003269 201003272 201003273 201006557 Amended 07/29/2021: US Products that Faceplates will be replaced Model: V60 Part Number: 1053616 V60 Ventilator, English Opt: None Serial Numbers: 100004031 100004071 100004073 100005244 100005350 100005351 100005599 100006209 100006210 100006217 100006406 100006701 100006702 100006881 100006883 100006886 100006888 100006891 100006929 100006933 100006939 100006940 100006941 100009417 100009501 100009512 100009513 100009549 100009550 100009553 100009554 100009556 100009566 100009679 100009760 100009761 100009762 100009768 100009769 100009770 100009777 100009812 100009816 100009854 100010206 100010242 100010390 100010514 100010515 100010517 100010519 100011308 100011343 100011344 100011468 100011740 100011741 100011744 100011749 100011750 100011751 100011754 100011791 100011794 100011799 100011801 100011820 100011821 100011822 100011823 100011824 100011825 100011826 100011827 100011828 100011829 100011830 100011831 100012694 100012884 100012887 100012890 100012891 100013021 100013023 100013027 100013032 100013034 100013083 100013667 100013669 100013791 100014073 100014088 100014142 100014147 100014153 100014283 100014286 100015076 100015209 100015213 100015281 100015667 100016078 100016597 100016599 100016736 100016746 100016747 100016749 100017103 100017258 100017287 100017293 100017301 100017302 100019586 100020214 100020215 100020217 100020219 100020220 100020227 100020312 100020314 100020316 100020317 100020445 100020885 100021037 100021042 100021874 100021877 100021968 100023238 100024476 100024484 100025989 100026618 100026620 100026805 100026806 100026807 100026816 100027758 100029842… (truncated, 6780 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1053617 V60 Ventilator, English Opt: None Serial Numbers: 201000151 100109977 100090432 100091177 100091771 100092004 100092037 100113859 100008140 100009121 100066005 100067771 100068862 100068864 100068866 100229881 100229933 100229936 100244028 100244036 100244037 100342231 201013345 201030470 201030473 201030478 MX0000810 MX0000813 MX0000825 MX0000828 100002909 100002910 100002912 100002915 100002998 100002999 100003000 100003002 100003004 100003006 100003019 100003040 100003041 100003042 100003043 100003044 100003045 100003047 100003048 100003049 100003050 100003051 100003053 100003080 100003082 100003083 100003084 100003085 100003086 100003087 100003088 100003089 100003090 100003091 100003092 100003148 100003149 100003658 100003659 100003661 100003662 100003663 100003664 100003665 100003666 100003667 100003668 100003669 100003670 100003671 100003672 100003673 100003680 100003681 100003682 100003683 100003684 100003686 100003687 100003688 100003690 100003691 100003692 100003725 100003726 100003727 100003729 100003730 100003731 100003732 100003733 100003734 100003735 100003737 100003738 100003739 100003746 100003747 100003748 100003749 100003750 100003751 100003752 100003753 100003754 100003755 100003756 100003758 100003759 100003760 100003860 100003861 100003862 100003863 100003864 100003901 100003902 100003903 100003904 100003905 100003906 100003907 100003908 100003911 100003912 100003914 100003915 100003917 100004016 100004017 100004018 100004019 100004020 100004021 100004022 100004023 100004024 100004025 100004026 100004027 100004028 100004029 100004030 100004034 100004035 100004072 100004074 100004075 100004076 100004078 100004079 100004080 100004082 100004083 100004084 100004085 100004121 100004126 100004129 100004130 100004132 100004133 100004134 100004135 100004136 100004137 100004138 100004139 100004321 100004541 100004544 100004546 100004551 100004552 100004559 100004980 100004981 100004989 100004990 100004991 100004993 100004996 100004997 100004998 100005100 100005101 100005102 100005103 100005104 100005105 100005106 100005107 100005108 100005109 100005111 100005112 100005113 100005114 100005115 100005118 100005119 100005140 100005142 100005143 100005144 100005145 100005146 100005148 100005149 100005151 100005152 100005153 100005154 100005155 100005156 100005157 100005158 100005159 100005235 100005236 100005237 100005238 100005240 100005243 100005245 100005246 100005248 100005249 100005250 100005252 100005253 100005254 100005325 100005326 100005327 100005328 100005329 100005330 100005331 100005332 100005333 100005335 100005336 100005337 100005339 100005340 100005341 100005342 100005344 100005348 100005349 100005353 100005354 100005355 100005356 100005357 100005358 100005359 100005387 100005389 100005390 100005391 100005393 100005394 100005395 100005396 100005397 100005398 100005399 100005400 100005401 100005402 100005403 100005404 100005405 100005484 100005485 100005487 100005488 100005490 100005492 100005493 100005494 100005495 100005496 100005497 100005498 100005499 100005500 100005501 100005502 100005503 100005581 100005582 100005583 100005584 100005585 100005586 100005587 100005588 100005589 100005590 100005591 100005592 100005593 100005594 100005596 100005597 100005598 100005600 100005683 100005684 100005685 100005686 100005687 100005688 100005689 100005691 100005692 100005693 100005694 100005695 100005696 100005698 100005700 100005701 100005702 100005760 100005761 100005762 100005763 100005764 100005765 100005766 100006211 100006212 100006213 100006214 100006215 100006216 100006218 100006219 100006280 100006281 100006283 100006285 100006286 100006287 100006288 100006365 100006366 100006367 100006369 100006370 100006371 100006372 100006373 100006374 100006375 100006376 100006377 100006378 100006379 100006380 100006381 100006382 100006383 100006384 100006390 100006391 100006392 100006393 100006394 100006395 100006396 100006397 100006398 100006399 100006400 100006401 100006402 100006403 100006404 100006405 100006407 100006408 100006409 100006520 100006521 100006522 100006523 100006524 100006525 100006526 100006527 100006528 100006529 100006530 100006531 100006532 100006533 100006534 100006535 100006536 100006537 100006538 100006539 100006587 100006588 100006589 100006590 100006591 100006592 100006593 100006594 100006595 100006596 100006597 100006598 100006599 100006600 100006601 100006602 100006603 100006604 100006605 100006606 100006687 100006688 100006689 100006690 100006691 100006692 100006693 100006694 100006695 100006696 100006697 100006698 100006699 100006700 100006703 100006705 100006706 100006882 100006885 100006889 100006890 100006894 100006895 100006896 100006897 100006898 100006899 100006900 100006928 100006930 100006931 100006935 100006936 100006937 100006938 100006942 100006943 100006944 100006945 100006946 100006947 100007030 100007031 100007032 100007033 100007034 100007035 100007036 100007037 100007038 100007039 100007040 100007041 100007042 1000070… (truncated, 942803 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS  Serial Numbers: 100039155 100054624 100054738
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Plus Part Number: 1138747 V60 Plus Ventilator, US Serial Numbers: 100360666 100363973 100365901 100365983 100365987 100366525 100366542 100367657 100367660 100367732 100370559 100371789 100371876 100371995 100372119 100372901 100372903 100373102 100373106 100373116 100373117 100374141 100374143 100374149 100374168 100374169 100374171 100374236 100374238 100374283 100374285 100374287 100374291 100374406 100374410 100374453 100374456 100374458 100374459 100376350 100376351 100377022 100377275 100377278 100377304 100377307 100377315 100377334 100378833 100378838 100379236 100379341 100379350 100379351 100379352 100379368 100379432 100379438 100379462 100379465 100380046 100380441 100381016 100381020 100381021 100381023 100381024 100381025 100381029 100381049 100382407 100382409 100382413 100382428 100382429 100382432 100382433 100382436 100382439 100382440 100382446 100382448 100382450 100382454 100382460 100382463 100382468 100382469 100382472 100382479 100382481 100382482 100382486 100382491 100382492 100382494 100382496 100382503 100382507 100382509 100382522 100382526 100382529 100382531 100382547 100382548 100384413 100384416 100384680 100384706 100384707 100384710 100384713 100384715 100384717 100384723 100384732 100384735 100384742 100384743 100384747 100384759 100384763 100385374 100385409 100385416 100385421 100385424 100385432 100385437 100385458 100385499 100386092 100386113 100386133 100386142 100386157 100386161 100386162 100386163 100386180 100386181 100386192 100386194 100386196 100386198 100386199 100386205 100386221 100386226 100389961 100389962 100389964 100389978 100389979 100390065 100392648 100392657 100392800 100392808 100392810 100392811 100392815 100392825 100392826 100392828 100392833 100392838 100392840 100392843 100392848 100392850 100392853 100392854 100392855 100392857 100392861 100392862 100392866 100392870 100392871 100392872 100392873 100392874 100392880 100392881 100392883 100392893 100392895 100392901 100392904 100392910 100393193 100393211 100393214 100393215 100393216 100393217 100393218 100393219 100393491 100393492 100393493 100393541 100393542 100393546 100393548 100393549 100393550 100393551 100393552 100393553 100393554 100393555 100393557 100393558 100393570 100393572 100393573 100393574 100393584 100393585 100393729 100393730 100393733 100393739 100393741 100393742 100393743 100393744 100393745 100393747 100393748 100393750 100395458 100395459 100395480 100395481 100395482 100395483 100395484 100395485 100395486 100395488 100395489 100395490 100395491 100395492 100395493 100395494 100395495 100395496 100395497 100395498 100395499 100395500 100395501 100395502 100395503 100395504 100395505 100395506 100395507 100395509 100395511 100395512 100395513 100395514 100395515 100395517 100395518 100395519 100395520 100395521 100395522 100395523 100395524 100395525 100395526 100395527 100395701 100395702 100395703 100395704 100395705 100395706 100395707 100395708 100395709 100395711 100395713 100395714 100395715 100395716 100395717 100395718 100395719 100395800 100395801 100395802 100395803 100395804 100395805 100395806 100395807 100395808 100395809 100395810 100395994 100395995 100395996 100395997 100395998 100395999 100396000 100396001 100396002 100396003 100396004 100396005 100396006 100396007 100396008 100396009 100396010 100396011 100396012 100396013 100396014 100396015 100396016 100396018 100396019 100396020 100396021 100396022 100396023 100396116 100396117 100396118 100396119 100396121 100396122 100396123 100396124 100396125 100396126 100396127 100396128 100396129 100396130 100396132 100396133 100396134 100396136 100396138 100396139 100396140 100396142 100396144 100396145 100396147 100396148 100396150 100396151 100396152 100396154 100396155 100396156 100396157 100396158 100396159 100396162 100396163 100396164 100396165 100396166 100396167 100396168 100396169 100396170 100396171 100396172 100396173 100396174 100396175 100396176 100396177 100396178 100396521 100396522 100396523 100396524 100396525 100396526 100396528 100396529 100396530 100396531 100396534 100396536 100396537 100396538 100396539 100396563 100396564 100396565 100396566 100396568 100396569 100396570 100396571 100396572 100396573 100396574 100396576 100396577 100396578 100396579 100396587 100396588 100396589 100396591 100396594 100396596 100396597 100396599 100396600 100396601 100396742 100396743 100396744 100396756 100396758 100396759 100396760 100396761 100396762 100396763 100367642 100372347 100374144 100374170 100374457 100374460 100377281 100377293 100377305 100377310 100377311 100377314 100377316 100377324 100377327 100377329 100377330 100377331 100377332 100377336 100377337 100381027 100382403 100382408 100382431 100382434 100382435 100382441 100382442 100382443 100382444 100382445 100382447 100382477 100382515 100382524 100382525 100382527 100382535 100382536 100382538 100382539 100382543 100382546 100384517 100384518 100384748 100385393 100385399 100385403 100385411 100385412 100385414 10… (truncated, 50200 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1076716 V60 Ventilator, CHINA OPT: CFLEX, AVAPS  Serial Numbers: 100193935 100194169 100030124 100030335 100030359 100030360 100030761 100030762 100030763 100030764 100030766 100030767 100030768 100030769 100030770 100030771 100030773 100030775 100030776 100030777 100030779 100030782 100030783 100030784 100032461 100032686 100032687 100032688 100032689 100032690 100032691 100032692 100032695 100032697 100032698 100032701 100032702 100035773 100035778 100035779 100035896 100035897 100035898 100035899 100035900 100035901 100035902 100035903 100035904 100035907 100035909 100035910 100035911 100035913 100035914 100035918 100035919 100035926 100036047 100036302 100036306 100036307 100036310 100036311 100036313 100036314 100036316 100036317 100036320 100036432 100036433 100036434 100036439 100037365 100037366 100037367 100037368 100037369 100037370 100037371 100037372 100037373 100037374 100037375 100037376 100037377 100037378 100037379 100037380 100037382 100037383 100037384 100037385 100037386 100037387 100037388 100037389 100037390 100037391 100037392 100037393 100037394 100037395 100037541 100037542 100037548 100037551 100037559 100037561 100037562 100037563 100037564 100039784 100039789 100039973 100040077 100040088 100043091 100043304 100043306 100043307 100043308 100043309 100043310 100043311 100043312 100043318 100043320 100043321 100043941 100043942 100043943 100043946 100043947 100043950 100043953 100046144 100046153 100046155 100046158 100046160 100046161 100046162 100046163 100046546 100046745 100047058 100047068 100049056 100049057 100049058 100049059 100049060 100049061 100049062 100049063 100049064 100049065 100049068 100049069 100049070 100049072 100049076 100049077 100050076 100051086 100051087 100051090 100051091 100051092 100051093 100051094 100051095 100051096 100051097 100051098 100051320 100051321 100051322 100051323 100051324 100051325 100051326 100051327 100051328 100051329 100051330 100051332 100051333 100051334 100051335 100051336 100051337 100051338 100051339 100051340 100051341 100051342 100051343 100051344 100051345 100051346 100051347 100051348 100051349 100051965 100052401 100052403 100052407 100052411 100052413 100052414 100052415 100052416 100052417 100052524 100052525 100052526 100052527 100052528 100052529 100052530 100052531 100052532 100052533 100052534 100052535 100052536 100052537 100052538 100052747 100052841 100052843 100052853 100052942 100052943 100052948 100052952 100052953 100052954 100052955 100052956 100052957 100052958 100052959 100052960 100052961 100052962 100052963 100052964 100052965 100052966 100053047 100053048 100053049 100053051 100053052 100053053 100053054 100053055 100053056 100053057 100053058 100053059 100053060 100053061 100053062 100053063 100053065 100053066 100053067 100053068 100053069 100053071 100053072 100053073 100053074 100053075 100053581 100053582 100053583 100053584 100053585 100053587 100053588 100053589 100053590 100053591 100053592 100053593 100053595 100053597 100053599 100053601 100053678 100053681 100053683 100053687 100053689 100053690 100053691 100053693 100053695 100053778 100053787 100053789 100053790 100053791 100053792 100055717 100055808 100055809 100055810 100055811 100055812 100055813 100055814 100055816 100055817 100055818 100055819 100055820 100055821 100055822 100057204 100057207 100057208 100057209 100057210 100057211 100057212 100057215 100057352 100057379 100058322 100058323 100058324 100058325 100058326 100058327 100058328 100058329 100058330 100058331 100058332 100058333 100058334 100058335 100058336 100058337 100058338 100058339 100058340 100058341 100058473 100058474 100058475 100058476 100058477 100058478 100058479 100058480 100058481 100058482 100058483 100058484 100058485 100058486 100058488 100058492 100058558 100058560 100058564 100058567 100058569 100058570 100058571 100058833 100058834 100058836 100058838 100058841 100058912 100059167 100059170 100059171 100059247 100059250 100060392 100060393 100060405 100060415 100060585 100060591 100060593 100060594 100060597 100060599 100060600 100061623 100061624 100061628 100061630 100061631 100061632 100061633 100061634 100061643 100061644 100061647 100061648 100063165 100063172 100063173 100063174 100063175 100063176 100063178 100063179 100063271 100063272 100063273 100063274 100063275 100063276 100063277 100063278 100063279 100063280 100063281 100063282 100063283 100063284 100063285 100063286 100063287 100063288 100063290 100063291 100063292 100063294 100063297 100064513 100064514 100064515 100064516 100064517 100064518 100064519 100064520 100064521 100064522 100064523 100064534 100064564 100064569 100064573 100064668 100064671 100064672 100064673 100064674 100064675 100064676 100064677 100064698 100064699 100064703 100064720 100064721 100064722 100064831 100064832 100064833 100064835 100064836 100065341 100065497 100065499 100065508 100065509 100065511 100065515 100065591 100065592 100065598 100065600 100065602 100065605 100067434 100067452 1… (truncated, 102998 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1076717 V60 Ventilator, CHINA OPT: NONE  Serial Numbers: 100033299 100033300 100033301 100033302 100033303 100033304 100033305 100033306 100033308 100033309 100033310 100033311 100033312 100033313 100033314 100033315 100033316 100033317 100033318 100033319 100033320 100033321 100033322 100033323 100033562 100033563 100033564 100033565 100033566 100033567 100033568 100033569 100033570 100033571 100033572 100033573 100033574 100033575 100033576 100033577 100033578 100033579 100033580 100033581 100033582 100033583 100033584 100033585 100033586 100033587 100033588 100033589 100033590 100033591 100033592 100033593 100033594 100033595 100033645 100033646 100033647 100033648 100033649 100033650 100033651 100033652 100033653 100033654 100033730 100033731 100033732 100033733 100033734 100033735 100033736 100033737 100033738 100033739 100033740 100033741 100033742 100033743 100033744 100033745 100033746 100033747 100033748 100033749 100033750 100033751 100033752 100033753 100033754 100033756 100033757 100033758 100033759 100033762 100033894 100033897 100033898 100033910 100033912 100034502 100034503 100034504 100034505 100034506 100034507 100034508 100034509 100034510 100034511 100034512 100034513 100034514 100034515 100034516 100034517 100034518 100034520 100034521 100034522 100034523 100035774 100035775 100035776 100035777 100035905 100035906 100035908 100035916 100035917 100035920 100035921 100035922 100035923 100035924 100035925 100035927 100035928 100036020 100036021 100036022 100036038 100036039 100036040 100036041 100036042 100036043 100036044 100036045 100036046 100036089 100036090 100036091 100036092 100036093 100036095 100036135 100036136 100036137 100036138 100036139 100036140 100036141 100036142 100036144 100036145 100036146 100036148 100036149 100061636 100061639 201002856 201002857 201002858 201002859 201002920 201002921 201002922 201002923 201002924 201002925 201002926 201002927 201002928 201002929 201002930 201002931 201002932 201002933 201002934 201002935 201002936 201002938 201002939 201002940 201002941 201002942 201002960 201002961 201002962 201002963 201002964 201002965 201002968 201002969 201002970 201002971 201002972 201002973 201002974 201002975 201002983 201004069
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)