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Recalls affecting Maryland

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

16,826 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
UnclassifiedRisk not yet known
Medical deviceRecalled October 1, 2020

EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

Full report

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

Recall #:
86516
Lot/product code:
Lot Numbers: P826, P815, P796, P776
Recalling firm:
Epitope Diagnostics, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 8, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131

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

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-0057-2021
Lot/product code:
a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021
Recalling firm:
Denton Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 8, 2020

Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

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

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-0056-2021
Lot/product code:
N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
Recalling firm:
Denton Pharma, Inc.
View official FDA record (opens in a new tab)
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)
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries & Oatmeal. SKU: TB-BLOT-5 and TB-BLOT-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: 819573015072.

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-0067-2021
Lot/product code:
BB 07 APR 2021 20098 BB 08 APR 2021 20099 BB 09 APR 2021 20100 BB 18 MAY 2021 20139 BB 19 MAY 2021 20140 BB 16 JUN 2021 20168 BB 28 AUG 2021 20241
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 Numbers: 35B1300004 35B1300010 35B1300019 35B1300021 35B1300022 35B1300025 35B1300036 35B1300037 35B1300045 35B1300046 35B1300013 35B1300041 35B1300006 35B1300008 35B1300009 35B1300027 35B1300051 35B1300016 35B1300042 35B1300005 35B1300026 35B1300031 35B1300001 35B1300040 35B1300050 35B1300020 35B1300033 35B1300030 35B1300044 35B1300011 35B1300048 35B1300035 35B1300002 35B1300029 35B1300038 35B1300014 35B1300017 35B1300003 35B1300015 35B1400001 35B1300018 35B1300034 35B1300007 35B1300032 35B1300043 35B1400005 35B1400010 35B1400013 35B1400020 35B1400024 35B1400009 35B1400028 35B1400017 35B1400025 35B1400023 35B1400011 35B1400021 35B1400032 35B1400033 35B1400034 35B1400040 35B1400003 35B1400026 35B1400030 35B1400035 35B1400044 35B1400048 35B1400055 35B1400056 35B1400059 35B1400060 35B1400061 35B1400063 35B1400049 35B1400068 35B1400069 35B1400050 35B1400062 35B1400064 35B1400072 35B1400007 35B1400015 35B1400058 35B1400077 35B1400083 35B1400057 35B1400041 35B1400066 35B1400070 35B1400087 35B1400088 35B1400092 35B1400074 35B1400091 35B1400039 35B1400071 35B1400075 35B1400012 35B1400042 35B1400053 35B1400065 35B1400079 35B1400080 35B1400095 35B1400073 35B1400082 35B1400038 35B1400036 35B1400097 35B1400101 35B1400104 35B1400067 35B1400047 35B1400006 35B1400103 35B1400110 35B1400112 35B1400113 35B1400116 35B1400111 35B1400108 35B1400109 35B1400098 35B1400081 35B1400096 35B1400022 35B1400105 35B1400119 35B1400122 35B1400123 35B1400124 35B1400126 35B1400100 35B1400129 35B1400130 35B1400132 35B1400137 35B1400134 35B1400131 35B1400135 35B1400115 35B1400127 35B1400027 35B1400084 35B1400138 35B1400093 35B1400133 35B1400141 35B1400149 35B1400142 35B1400145 35B1400147 35B1400150 35B1400153 35B1400051 35B1400136 35B1400152 35B1400139 35B1400037 35B1400159 35B1400078 35B1400089 35B1400114 35B1400117 35B1400120 35B1400140 35B1400143 35B1400151 35B1400155 35B1400157 35B1400158 35B1400172 35B1400164 35B1400154 35B1400161 35B1400162 35B1400018 35B1400160 35B1400174 35B1400176 35B1400179 35B1400004 35B1400156 35B1400198 35B1400191 35B1400197 35B1400099 35B1400165 35B1400169 35B1400180 35B1400217 35B1400182 35B1400170 35B1400148 35B1400189 35B1400194 35B1400106 35B1400118 35B1400166 35B1400171 35B1400185 35B1400188 35B1400192 35B1400199 35B1400210 35B1400228 35B1400203 35B1400233 35B1400184 35B1400195 35B1400201 35B1400227 35B1400187 35B1400196 35B1400102 35B1400205 35B1400206 35B1400208 35B1400214 35B1400181 35B1400190 35B1400209 35B1400230 35B1400239 35B1400247 35B1400249 35B1400193 35B1400251 35B1400252 35B1400221 35B1400167 35B1400207 35B1400211 35B1400219 35B1400222 35B1400260 35B1400212 35B1400224 35B1400241 35B1400242 35B1400246 35B1400218 35B1400229 35B1400232 35B1400237 35B1400235 35B1400146 35B1400173 35B1400216 35B1400220 35B1400225 35B1400226 35B1400231 35B1400259 35B1400262 35B1400265 35B1400274 35B1400283 35B1400186 35B1400223 35B1400215 35B1400248 35B1400261 35B1400266 35B1400268 35B1400243 35B1400250 35B1400254 35B1400163 35B1400255 35B1400256 35B1400267 35B1400270 35B1400273 35B1400275 35B1400278 35B1400281 35B1400287 35B1400290 35B1400303 35B1400253 35B1400279 35B1400285 35B1400177 35B1400213 35B1400245 35B1400264 35B1400282 35B1400284 35B1400286 35B1400288 35B1400289 35B1400296 35B1400302 35B1400305 35B1400307 35B1400292 35B1400298 35B1400168 35B1400293 35B1400310 35B1400313 35B1400316 35B1400318 35B1400320 35B1400291 35B1400272 35B1400309 35B1400234 35B1400295 35B1400322 35B1400090 35B1400238 35B1400258 35B1400317 35B1400324 35B1400326 35B1400327 35B1400328 35B1400204 35B1400271 35B1400301 35B1400306 35B1400312 35B1400315 35B1400323 35B1400340 35B1400341 35B1400333 35B1400332 35B1400336 35B1400338 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
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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

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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
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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.

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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.

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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.

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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.

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

Potential for a false-negative result.

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

Potential for a false-negative result.

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

Potential for a false-negative result.

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

Potential for a false-negative result.

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

Potential for a false-negative result.

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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 October 30, 2020

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

Potential for a false-negative result.

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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 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 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 Ventilator Part Number R1076709 - 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: R1076709 V60 Ventilator, JAPAN OPT: CFLEX,AVAPS,AT+  Serial Numbers: 100065352 100065365 100065371 100065487 100065493 100067423 100067425 100067428 100067431 100067451 100068214 100069518 100070301 100070306 100070398 100070476 100070491 100070492 100070768 100070774 100070776 100070777 100070778 100070780 100070781 100070859 100070862 100070865 100070921 100070922 100070924 100070928 100070929 100070930 100070935 100070966 100070969 100070973 100070976 100070981 100071071 100071073 100071077 100071123 100071461 100071510 100071511 100072415 100072417 100072418 100072499 100072570 100072606 100072607 100072673 100072676 100072679 100072684 100072685 100072688 100072690 100072695 100074195 100075099 100075100 100075104 100075189 100075293 100075312 100075381 100078120 100078132 100078140 100078145 100078266 100078302 100078313 100078362 100078365 100078366 100078372 100079387 100080231 100080233 100080236 100080237 100080239 100080271 100080275 100080276 100080277 100080282 100080285 100080290 100080291 100080292 100080294 100080295 100080297 100080298 100080421 100080422 100080423 100080424 100080425 100080427 100080428 100080429 100080430 100080528 100080529 100080530 100080532 100080533 100080535 100080536 100080537 100080540 100080541 100080542 100080543 100080544 100080545 100080547 100080552 100080553 100080563 100080642 100080643 100080644 100080647 100080650 100080651 100080652 100080653 100080654 100080657 100080658 100080659 100080704 100080706 100080708 100080711 100080713 100080716 100080717 100080721 100080722 100080723 100080724 100080725 100080726 100080729 100080731 100080733 100080734 100080736 100080740 100080840 100080841 100080843 100080845 100080846 100080847 100080849 100080850 100080852 100081698 100083532 100083534 100083537 100083538 100083539 100083561 100083563 100083564 100083567 100083569 100083577 100083601 100083603 100083811 100083813 100083816 100083817 100083821 100083822 100083823 100083824 100083825 100083828 100083830 100083832 100083833 100083920 100083921 100083922 100083923 100083924 100083925 100083926 100083927 100083929 100083930 100084955 100084957 100085084 100085086 100085087 100085089 100085090 100085092 100085095 100085242 100085245 100085248 100085249 100085250 100085253 100085322 100085323 100085324 100085325 100085326 100085328 100085329 100085331 100085332 100085334 100085336 100085337 100085338 100085339 100085380 100085381 100085383 100085385 100085386 100085387 100085388 100085395 100085397 100085480 100085482 100085484 100085485 100085486 100085487 100085488 100086236 100086783 100086891 100086896 100086902 100087025 100087028 100087049 100087050 100087052 100087093 100087095 100087097 100087103 100087104 100087172 100087344 100087350 100087351 100087352 100087353 100087354 100087357 100087358 100087462 100087463 100087464 100087465 100087468 100087471 100087472 100087474 100087475 100087477 100087478 100087482 100087484 100087488 100087489 100087602 100087607 100087608 100087609 100087612 100087613 100087616 100087617 100087682 100087683 100087684 100087685 100087691 100087693 100087695 100087696 100087697 100087698 100087699 100088046 100088054 100088055 100088059 100088060 100088429 100088432 100088433 100088434 100088435 100088437 100088438 100088439 100088859 100089023 100089024 100089025 100089026 100089027 100089028 100089029 100089030 100089031 100089032 100089120 100089121 100089123 100089124 100089125 100089126 100089128 100089129 100089130 100089132 100089133 100089134 100089135 100089136 100089138 100089140 100089141 100089142 100089143 100089144 100089145 100089146 100089147 100089148 100089260 100089261 100089262 100089263 100089264 100089266 100089267 100089268 100089270 100089271 100089272 100089274 100089275 100089276 100089277 100089278 100089279 100089280 100089437 100089438 100089440 100089441 100089443 100089444 100089445 100089446 100089447 100089448 100089450 100089451 100089459 100089460 100089462 100089463 100089464 100089802 100089803 100089804 100090135 100090531 100090545 100090547 100090550 100090552 100090553 100090557 100090652 100090654 100090658 100090665 100090668 100090670 100090672 100090674 100090677 100090680 100090681 100090778 100090779 100090781 100090782 100090784 100090786 100090787 100090788 100090789 100090792 100090794 100090796 100090797 100090798 100090799 100090800 100090801 100090803 100090804 100090805 100090914 100090917 100090919 100090922 100090926 100090927 100090928 100090929 100090930 100091265 100091390 100091393 100091398 100091400 100091402 100091404 100091405 100091721 100091725 100091727 100091731 100091733 100091734 100091736 100091740 100091741 100091742 100091744 100091746 100091819 100091840 100091844 100091846 100091850 100091856 100091861 100091862 100091865 100091866 100091867 100091918 100091919 100100747 100100850 100100995 100100997 100100998 100100999 100101056 100101060 100101062 100101063 100101066 100101067 100101074 100101396 100101400 100101402 1001014… (truncated, 32222 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 V680 Ventilator Part Number 850011 - 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: V680 Part Number: 850011 V680 Ventilator, Finished  Serial Numbers: 201009427 201009428 201009429 201009493 201009494 201009495 201009496 201009498 201009499 201009660 201009661 201009662 201009663 201009664 201009665 201009666 201009667 201009668 201009669 201009670 201009671 201009672 201009673 201009675 201009676 201009677 201009678 201009679 201009674 201008743 201008765 201008766 201008770 201008771 201008776 201008785 201008786 201008805 201009497 201008801 201008741 201008744 201008760 201008764 201008767 201008768 201008772 201008775 201008783 201008808 201008762 201008773 201008781 201008809 201008807 100124645 100124646 100125009 100125011 100125012 100125013 100125014 100125148 100125149 100125150 100125152 100125153 100125154 100125155 201008740 201008742 201008774 201008777 201008802 201008804 100125541 100125544 201008780 201008800 201008803 100125504 100125505 100125509 100125512 100125542 100125545 100125550 100125551 100125552 201008784 100125508 100125546 100125549 100125010 100125516 100125517 100125151 100125515 100125547 201008782 100125513 100125510 100129145 201010488 201010551 201010627 100129141 100129142 100129143 201010254 201010535 201010546 201010674 100126254 100129144 100134076 201010428 201010482 201010490 201010536 201010548 201010620 201010622 201010675 100125518 100129147 100134077 201010255 201010360 201010434 201010485 201010538 201010623 201011218 100125553 100129146 100129148 100134073 100134074 100134075 100134078 100134079 100134180 100134181 100134182 100134183 201010251 201010252 201010256 201010257 201010258 201010259 201010426 201010427 201010429 201010430 201010438 201010484 201010491 201010537 201010539 201010540 201010544 201010545 201010547 201010550 201010552 201010553 201010624 201010625 201010626 201011216 201011217 201011220 100134184 201010439 201010483 100134337 100135409 100125543 100134335 100135396 100135398 100135400 100135401 100135402 100135404 100135405 100135406 100135407 100135631 100135633 100135634 100135635 100135636 100135638 100135639 100135630 100135637 100135642 100135644 100135650 201011219 100135640 100135641 100135643 100135647 100135652 100135397 100135645 100135646 100135648 100135649 100135651 100135653 100135654 100135655 100137426 100137427 100137428 100137429 100137430 100137431 100137433 100137434 100137436 100137437 100137438 100137439 100137440 100137444 100137446 100137447 100137448 100137449 100137450 100138009 100138010 100138011 100138012 100138016 100138017 100138018 100138019 100138508 100138510 100135403 100135632 100137435 100137442 100137443 100137445 100138013  100138080 100138082 100138507 100137432 100137441 100138008 100138081 100138083 100138086 100138087 100138503 100138512 100138513 100138514 100138515 100138522 100138084 100138085 100138509 100138511 100138517 100138518 100138519 100138520 100138521 100138705 100138707 100138814 100138816 100138818 100138943 100139067  100138506 100138516    100138819 100138940 100138941 100138942 100139064 100139066 100139068 100139069 100139070 100139071 100139074 100139075 100139077 100139078 100139079 100139080 100139082 100139083 100139084 100139087 100140238 100140239 100140300 100140301 100140302 100140303 100140304 100140305 100140310 100140311 201012739 201013230 201013231 100139076 100139081 100139088 100140308 100140315 100140317 201012733 201012735  201013213 201013220 201013221 201013224 201013225 201013226 201013228 201013229 100138504 100139072 100139085 100140312 100140314 100140316 201012732 201012734 201012736 201013209 201013210 201013211 201013212 201013215 201013223 201013227 201013233 201013234 201013235 100139065 100139073 100140309 201012738 201013214 201013236 100139086 100140306 100140313 100142426 100142428 100142429 100142431 100142432 100142434 100142437 100142460 201013217 201013218 201013219 201013222 100135399 100135408     100142637 100142427 100142436 100142438 201013216 201013232 100142634 100142435 100142638 100142640 100142641 100142635 100142636 100142642 201013271 201013272 201013275 201013273 201013276 201013279 201013720 201013725 201013747 100142639 201013274 201013277 201014176 201014178 201014179 201014182 201014183 201014211 201014213 201013713 201013717 201013749 201013887 201014185 201014214 201013890 201014177 201014181 201014184 201014196 201014198 201014199 201014215 201014216 201014217 201014218 201014219 201013709 201013710 201013711 201013712 201013714 201013715 201013716 201013724 201013744 201013748 201013750 201013753 201013888 201013889 201013891 201013893 201014197 201014340 201014180 201014324 201014342 201014388 201014195 100146372 100146374 201014322 201014323 201014326 201014328 201014386 100146369 100146370 100146371 100146373 100146873 201014321 201014325 201014327 201014341 201014343 201014344 100147209 100146442 100146875 100146375 100146876 100147212 201014544 100147217 201014534 201014536 201014542 201014600 201014538 100147215 100146376 100146377 100146440 100146443 100146872 100147218 100147300 20101… (truncated, 33981 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)