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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Suction Canister Liners and Kits Recalled for Fitting Defects

Agency Publication Date: August 22, 2024
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Summary

Medline Industries is recalling 604,924 suction canister liners and various medical procedure kits that contain them due to a manufacturing defect. The affected products have a slight dimensional variation that makes it difficult to fit the liner into the outer suction canister used during medical procedures. This recall involves multiple product models including soft liners and complex medical kits for anesthesia, endoscopy, and surgical procedures distributed worldwide between May 2022 and December 2023.

Risk

If a liner does not fit correctly into its canister during a medical procedure, it may cause delays in critical suctioning or lead to a loss of suction. This failure could result in the inability to properly clear a patient's airway or surgical site of fluids, potentially leading to patient harm or surgical complications.

What You Should Do

  1. Identify if you have the affected products by checking for the Reference (REF) numbers on your packaging, such as DYNDSCL1500, OR929K, OR926K, OR53926, OR53929, OR1920PG, and various DYNJ-series procedure kits.
  2. Cross-reference your product with the extensive list of affected lot numbers, which include sequences starting with '670' (e.g., 670220523) and kit-specific codes like 22EBD700, 23DBF522, and 23KBR755.
  3. Examine the UDI/DI codes on the package and unit levels, such as 40884389129532 and 10884389129531, to confirm a match with the recalled batch.
  4. Stop using the affected suction liners immediately and quarantine any remaining stock to prevent further use in clinical settings.
  5. Contact Medline Industries, LP at their Northfield, Illinois headquarters or your specific Medline representative to coordinate the return or exchange of affected products.
  6. Healthcare providers should consult with their facility's risk management or clinical engineering departments regarding any patients who may have been impacted by equipment fitting issues.
  7. For additional information or technical questions, contact the FDA Medical Device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and Return

How to: Contact your healthcare provider or Medline Industries for further instructions on returning the product and receiving replacements.

Affected Products

Product: LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
Model / REF:
DYNDSCL1500
UPC Codes:
40884389129532
10884389129531
Lot Numbers:
670220523
670220531
670220613
670220530
670220624
670220704
670220713
670220727
670220721
670220804
670220912
670220916
670220901
670221013
670221026
670221103
670221129
670221207
670221210
670221224
670230103
670230208
670230220
670230306
670230313
670230327
670230414
670230422
670230427
670230510
670230518
670230525
670230925
670231006
670231020
670231103
670231114
670231201
670231127
Product: LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
Model / REF:
OR929K
UPC Codes:
40888277276209
10888277276208
Lot Numbers:
670220928
670221020
670221010
670221121
670221128
670230317
670230419
Product: 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
Model / REF:
OR926K
UPC Codes:
40888277276223
10888277276222
Lot Numbers:
670220510
670220607
670220701
670220727
670220721
670220825
670221115
670220915
670220928
670221024
670221220
670221124
670221213
670221202
670221222
670230206
670230215
670230417
670230331
670230508
670230922
670231019
670231101
670231123
670231116
670231205
Product: 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
Model / REF:
OR53926
UPC Codes:
40888277422279
Lot Numbers:
670220512
670220609
670220621
670220629
670220712
670220803
670220815
670220914
670221009
Product: 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
Model / REF:
OR53929
UPC Codes:
40888277422286
Lot Numbers:
670220505
670220609
670220621
670220720
670220804
670220926
670220928
670221024
670221115
670221227
670230109
670230210
670230424
Product: 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
Model / REF:
OR1920PG
UPC Codes:
20888277660103
Lot Numbers:
670220511
670220622
670220628
670220706
670220720
670220801
670220805
670220907
670220912
670221020
670221115
670221128
670221205
670221213
670221219
670221223
670230105
670230213
670230308
670230322
670230424
670230530
670230601
Product: ANESTHESIA CIRCUIT ADULT / CV ANESTHESIA KITS
Model / REF:
DYNJAAF6666B
DYNJAP9918A
DYNJ905503F
UPC Codes:
40195327505838
40195327505883
40889942131410
Lot Numbers:
22EBD700
22GBK692
22KBE980
23DBF522
23GBU504
23IBJ329
23LBD558
22EBC460
22HBK483
22IBT280
22JBC030
22KBG647
23IBM414
22FBR267
22GBR286
22HBS560
22IBA577
22JBI883
22KBD587
22LBF425
23BBN903
23CBL450
23CBW776
23FBC209
23IBU343
23JBP494
23KBH749
23KBQ236
Product: MEDLINE TURNOVER KIT / SUCTION SET UP KIT
Model / REF:
DYKC1274A
DYKC1309A
DYKM1187A
DYKM2169
UPC Codes:
40889942750154
40888277745903
40193489244732
40195327199969
Lot Numbers:
22FMA812
22HMH967
22LMD953
23DMA533
23EMH949
23GMH687
23JMJ195
DYKC1309A
22EMC363
22FMD877
22FMF873
22HMF347
22JMD898
23AMA723
23AMH732
23BMI255
23CME984
23FMB442
23GMC961
23HMA663
23JMB772
22IBJ207
22LBP008
23ABT182
23BBK494
23EBN628
23GBF762
23IBF429
23JBH402
23LBB872

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94356
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; Medical Supply Distributors; Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 18 products (88703 units; 35900 units; 316125 units; 1920 units; 26096 units; 99 units; 6998 units; 22891 units; 2588 units; 3400 units; 3539 units; 75098 units; 1700 units; 160 units; 2013 units; 964 units; 1753 units; 14977 units)
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.