Critical
Class I
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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FDA Recalls
Page 15 of 40 · 1,986 total recalls
Recalls — Page 15
Critical
Class I
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: DRAINAGE KIT/AK-01600
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Critical
Class I
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and...
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Warning
Class II
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical
Warning
Class II
Frederik's by meijer Vanilla Bourbon Trail Mix, packed in plastic retail-sized black bag NET WT 9 OZ (255g)
Undeclared allergens (wheat and soy).
Ferris Coffee and Nut Company
Warning
Critical
Class I
(BULK) SPL-BEV Banana CWT (Banana Smoothie); Super Sack Tote Item# 355-0099
Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products.
Honeyville
Critical
Class I
Automated Impella Controller (AIC); Product Code: 0042-0000-US
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential...
Abiomed
Warning
Class II
NAPROXEN ORAL SUSPENSION
Chemical contamination; presence of lead and lithium above specification
Acella Pharmaceuticals
Critical
Class I
Buttermilk Powder - paper bags 25 kg
Potential contamination with Salmonella.
California Dairies Inc.
Critical
Class I
Low Heat Non-Fat Dried Milk Powder - paper bags 25 kg
Potential contamination with Salmonella.
California Dairies Inc.
Critical
Class I
Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs
Potential contamination with Salmonella.
California Dairies Inc.
Warning
Warning
Class II
My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container
Foreign object found inside retail container.
The Mochi Ice Cream Company
Warning
Class II
Uncle Giuseppe's Marketplace Milk Chocolate Bridge Mix, 11 oz Net Wt, packed in clear tamper resistant plastic container
Contains undeclared allergens (cashews, milk, and soy).
WE R NUTS
Warning
Class II
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA
Lack of Assurance of Sterility
Harrow Eye LLC
Warning
Warning
Class II
Banana Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00903
Undeclared Yellow #5
Silver Moon LP dba Loard's Ice Cream
Info
Class III
Burgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC
Undeclared Red #40, Blue #1, Blue #2
Silver Moon LP dba Loard's Ice Cream
Warning
Class II
Chocolate Mint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC
Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1
Silver Moon LP dba Loard's Ice Cream