The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

14301–14325 of 21645

  • ModerateFDA (Devices)·Z-2154-2016·2016-07-20

    Synthes Recalls 7.0 mm and 7.3 mm Cannulated Screws for Labeling Errors

    Synthes (USA) Products LLC is recalling 7.0 mm and 7.3 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2016·2016-07-20

    Merge Healthcare Recalls OfficePACS Software Due to Data Loss Risk

    Merge Healthcare is recalling OfficePACS software versions 4.0 through 4.2 because a defect in the archiving function may cause potential data loss.

    Product
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1354-2016·2016-07-20

    Wupooser Kai Yeung Pill Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Wupooser Kai Yeung Pill because it is marketed with drug claims without FDA approval.

    Product
    WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2194-2016·2016-07-20

    Synthes Recalls 1.3mm Stardrive Screwdrivers for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 75 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2158-2016·2016-07-20

    Synthes Recalls 3.5 mm and 4.0 mm Cannulated Screws for Labeling Errors

    Synthes (USA) Products LLC is recalling 3.5 mm and 4.0 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1350-2016·2016-07-20

    Murray International Recalls Tien Ma Tou Tong Wan Pills for Unapproved Drug Claims

    Murray International Trading Co. is recalling Tien Ma Tou Tong Wan pills because they bear drug claims despite being marketed as dietary supplements.

    Product
    Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1356-2016·2016-07-20

    Ping On Ointment Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Ping On Ointment because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2189-2016·2016-07-20

    Synthes Low Profile Neuro Screwdriver Blade Recalled for MR Safety Labeling

    Synthes (USA) Products LLC is recalling 50 units of Low Profile Neuro Screwdriver Blades because the MR Safety information etched or labeled on the devices does not meet current ASTM standards.

    Product
    Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2016·2016-07-20

    Synthes 1.1mm Drill Bit Recalled for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 19 units of 1.1mm Drill Bits because their MR safety labeling does not meet current ASTM standards.

    Product
    Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2016·2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

    Apotex Scientific is recalling Duloxetine Delayed-Release Capsules, 60 mg, because stability testing revealed out-of-specification dissolution results.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1440-2016·2016-07-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling specific lots of Daytrana transdermal patches because the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1355-2016·2016-07-20

    Murray International Trading Recalls Farser Kai Yeung Pill for Unapproved Drug Claims

    Murray International Trading Co., Inc. is recalling Farser Kai Yeung Pill because it is marketed with drug claims without FDA approval.

    Product
    FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2016·2016-07-20

    Merge OfficePACS Software Recalled for Potential Data Loss

    Merge Healthcare is recalling OfficePACS software version 3.4 because archiving failures may cause data loss at 49 medical facilities.

    Product
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2195-2016·2016-07-20

    Synthes Recalls 34 Stardrive Screwdrivers for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 34 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2191-2016·2016-07-20

    Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR safety labeling does not meet current ASTM standards.

    Product
    Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2153-2016·2016-07-20

    Synthes 6.5 mm Cancellous Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 6.5 mm Cancellous Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1345-2016·2016-07-20

    Murray International Recalls Unapproved Facial Pigmentation Pills

    Murray International Trading Co. is recalling 84 bottles of facial pigmentation pills marketed without FDA approval. The products bear drug claims but are labeled as dietary supplements.

    Product
    PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1352-2016·2016-07-20

    Peking Niu-Huang Chieh-Tu-Pien Tablets Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Peking Niu-Huang Chieh-Tu-Pien Tablets because they bear drug claims without FDA approval.

    Product
    PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2156-2016·2016-07-20

    Synthes 4.5 mm Cortex Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 4.5 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1236-2016·2016-07-20

    Medaus Recalls Pyridoxine HCL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot ensure the product is sterile.

    Product
    PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1358-2016·2016-07-20

    Murray International Recalls Unapproved Flucinonide Ointment Cream

    Murray International Trading Co., Inc. is recalling 97 boxes of FUQINGSONG RELIEF CREAM because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1353-2016·2016-07-20

    Gastrodia Capsules Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Gastrodia Capsules because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2016·2016-07-20

    Synthes Recalls 2.0mm Stardrive Screwdrivers for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 79 units of 2.0mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1346-2016·2016-07-20

    ChingChunBao Anti-Aging Tablets Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling ChingChunBao Anti-Aging Tablets because they bear drug claims without an approved NDA or ANDA.

    Product
    ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987 01144 9, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2016·2016-07-20

    Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide